MRx Clinical Alert

Our Clinical Alert, published monthly, provides up-to-date clinical insight and drug information highlights, focusing on recent FDA actions, evidence-based clinical trials and practice guidelines, new product approvals, upcoming pipeline, and related timely clinical topics.

August 2017 (PDF / 142KB)

Hot Topic: FDA Approves Pangenotypic Salvage for Chronic Hepatitis C Virus (HCV)
On July 18, 2017, the Food and Drug Administration (FDA) granted priority approval to Gilead’s breakthrough therapy, Vosevi™, for adults with chronic HCV infection who have failed prior direct-acting antiviral (DAA) treatment. [more...]

Guidelines on the Peri-Operative Use of Antirheumatic Agents
The American College of Rheumatology (ACR) and the American Association of Hip and Knee Surgeons published collaborative guidelines on the perioperative use of antirheumatic medications in adults undergoing select elective total hip or knee arthroplasty. [more...]

Joint Position on Aromatase Inhibitor-Associated Bone Loss (AIBL) Issued
Aromatase inhibitors (AIs) suppress estrogen levels beyond that attained from natural menopause, thereby leading to accelerated bone loss and an increased risk of fracture. [more...]

Behavioral Health Corner: VAST-D: Antidepressant Switching versus Augmentation in MDD
Major depressive disorder (MDD) is a chronic, debilitating disorder affecting millions of adults annually in the U.S. Research shows that less than one-third of patients achieve remission with their first course of therapy. [more...]

Drug Information Highlights

Pipeline News: Upcoming Prescription Drug User Fee Act (PDUFA) Dates

Recent FDA Approvals

July 2017 (PDF / 136KB)

SCOTUS on Biosimilars
On June 12, 2017, the Supreme Court of the United States (SCOTUS) issued a unanimous decision in a case involving Sandoz (the manufacturer of biosimilar filgrastim-sndz [Zarxio®]) versus Amgen (the manufacturer of the originator product filgrastim [Neupogen®]). [more...]

Key Diabetes Outcomes Trials Published: Canvas and Devote
Patients with type 2 diabetes mellitus (T2DM) are at increased risk of cardiovascular (CV) complications compared to those without diabetes.[more...]

ACP Updates Osteoporosis Gudelines
Based on a systematic review of literature and evidence for specific pharmacotherapy treatments, the American College of Physicians (ACP) published an update to the 2008 guidelines for the treatment of low bone density and osteoporosis to prevent fractures in men and women. [more...]

CDC Advisory for Shigella
The Centers for Disease Control and Prevention (CDC) issued a Health Advisory for diagnosing and managing Shigella strains with possible reduced susceptibility to ciprofloxacin (e.g., minimum inhibitory concentration [MIC] of 0.12-1 μg). [more...]

Drug Information Highlights

Pipeline News: Upcoming Prescription Drug User Fee Act (PDUFA) Dates

Recent FDA Approvals

June 2017 (PDF / 273KB)

New Hepatitis C Virus (HCV) Statistics in the United States (U.S.)
The Centers for Disease Control and Prevention (CDC) has reported that the incidence of new HCV infection in the U.S. has nearly tripled in just 5 years, bringing the prevalence to its highest level in 15 years. [more...]

AUA/ASTRO/SUO Releases Prostate Cancer Guidelines
The American Urological Association (AUA), American Society for Radiation Oncology (ASTRO), and Society of Urologic Oncology (SUO) released updated prostate cancer guidelines. The guidelines emphasize shared decision making and stratify recommendations by cancer severity and risk group. [more...]

Practice Parameter Updated for Sublingual Immunotherapy (SLIT)
The American Academy of Allergy, Asthma, and Immunology (AAAAI) and the American College of Allergy, Asthma, and Immunology (ACAAI) have released a practice parameter update on the appropriate use of SLIT. The joint recommendations are based on direct evidence and/or accepted consensus opinion. [more...]

Joint Guideline Provides Management Recommendations for Syncope
The American College of Cardiology (ACC), American Heart Association (AHA), and the Heart Rhythm Society (HRS) published a joint guideline that systematically reviewed evidence to define, evaluate, diagnose, and treat adult and pediatric patients with suspected syncope. [more...]

Recent FDA Approvals

May 2017 (PDF / 234KB)

ICER Review of Rheumatoid Arthritis (RA) Immune Modulators
An estimated 1.5 million Americans are affected by RA, which can have periods of symptom flares and remission. New immunotherapy agents have been introduced to the market in recent years. [more...]

Expanded Indications for Hepatitis C Antivirals
Recently, the FDA expanded the indications for 3 direct-acting antivirals (DAA) used to treat chronic hepatitis C virus (HCV) infections. In April, Gilead’s sofosbuvir (Sovaldi®) and sofosbuvir/ledipasvir (Harvoni®) gained approval for use in children ≥ 12 years old or weighing ≥ 35 kg without cirrhosis or with compensated cirrhosis. [more...]

ADA Releases Updated Diabetic Retinopathy Guidelines
Diabetic retinopathy is the most frequent cause of new cases of blindness among adults in developed countries. The American Diabetes Association's (ADA) updated diabetic retinopathy position statement was published in the March 2017 edition of Diabetes Care and includes significant changes to the treatment options and diagnostic assessment since it was last released in 2002. [more...]

AGA Guidance on Long-term Use of Proton Pump Inhibitors (PPIs)
The long-term use of PPIs doubled in the U.S. from 1999 to 2012, resulting in an increase in adverse events by the same magnitude. The American Gastroenterological Association (AGA) states that, when PPIs are used appropriately, their benefits exceed their risks. [more...]

Recent FDA Approvals

April 2017 (PDF / 364KB)

Hot Topic: FDA Approves First Drug for Primary Progressive Multiple Sclerosis
Multiple sclerosis (MS) affects approximately 90 per 100,000 people in the United States (U.S.), about 15% of whom have primary progressive MS (PPMS). Relapsing MS (RMS) is characterized by exacerbations of neurologic symptoms, followed by periods of remission. [more...]

FOURIER: Final Results for Evolocumab Outcomes Trial
The highly anticipated final results of the FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial were simultaneously published in the New England Journal of Medicine and presented at the American College of Cardiology Scientific Sessions on March 17, 2017. [more...]

American Society of Interventional Pain Physicians (ASIPP) Guidelines
Numerous organizations have released guidelines for responsible opioid prescribing in an effort to combat the ever-increasing problem of opioid abuse. [more...]

Likelihood of Long-Term Opioid Use
The 2016 Centers for Disease Control and Prevention (CDC) Guidelines for Prescribing Opioids for Chronic Pain included recommendations for opioid product selection and duration of use; however, there are few data on the transition from acute to chronic opioid use. [more...]

Continued Use of Benzodiazepine in Older Adults Despite Safety Concerns
Benzodiazepine use in older adults is common and of particular concern due to associations between benzodiazepines and adverse outcomes such as falls, fractures, motor vehicle accidents, impaired cognition, and dementia. [more...]

Recent FDA Approvals

March 2017 (PDF / 257KB)

Hypertension in the Older Adult: Guidelines by the American College of Physicians (ACP) and American Academy of Family Physicians (AAFP)
The ACP and AAFP published evidence-based recommendations on the benefits and harms of higher (< 150 mmHg) versus lower (< 140 mmHg) systolic blood pressure (SBP) targets in the treatment of hypertensive adults, age 60 years and older. [more...]

Cystic Fibrosis (CF) Diagnosis Guidelines
In 2010, universal newborn screening (NBS) for CF was implemented in the United States. The majority of patients with a positive NBS have a diagnosis of CF confirmed by a high sweat chloride concentration (≥ 60 mmol/L) using sweat chloride testing. [more...]

American College of Physicians (ACP) Guidance for Chronic Low Back Pain
The ACP updated their 2007 guidelines on noninvasive treatment for chronic low back pain based on a systematic review of randomized controlled trials and other literature published through November 2016. [more...]

Pediatric Endocrine Society (PES) Guidelines for Growth Hormone Deficiency (GHD)
The PES updated their 2003 guidelines for growth hormone (GH) and insulin-like growth factor-I (IGF-I) treatment in children and adolescents. Distinction between GHD, primary IGF-I deficiency (PIGFD), and idiopathic short stature (ISS) are often unclear; therefore, the PES focuses on recommendations for diagnosing and managing these conditions. [more...]

Recent FDA Approvals

February 2017 (PDF / 507KB)

FDA Final Guidance: Nonproprietary Naming of Biologic Products
The Food and Drug Administration (FDA) has released the much-awaited final guidance on nonproprietary naming of biologics. This Guidance for Industry details the agency’s stance on naming newly-approved and previously-licensed biologics under the Public Health Service (PHS) Act. [more...]

Updates in Type 2 Diabetes Mellitus (T2DM) Therapy
The American Association of Endocrinologists (AACE) and the American College of Endocrinology (ACE) announced an update to their Comprehensive Type 2 Diabetes Management Algorithm. [more...]

American College of Cardiology (ACC) Guidance for Periprocedural Anticoagulation in Patients with Nonvalvular Atrial Fibrillation (NVAF)
The ACC published an expert consensus decision pathway intended to assist providers with periprocedural anticoagulation management in patients with NVAF. When deciding if an interruption in anticoagulation is needed, providers should consider the type and half-life of the oral anticoagulant, the patient’s bleeding risk, the bleeding risk of the procedure, and other patient-specific clinical information. [more...]

Recent FDA Approvals

January 2017 (PDF / 342KB)

Empagliflozin Gains Cardiovascular (CV) Risk Reduction Indication
Empagliflozin (Jardiance®; Boehringer Ingelheim), which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM), has received a new indication. [more...]

Mylan Launches First Authorized Generic for Epipen®
Mylan, the manufacturer of Epipen, announced the much-awaited launch of the authorized generic, epinephrine injection USP. The authorized generic contains the same device functionality, drug formulation, and administration as the brand name Epipen auto-injector. [more...]

ADA’s Standards of Medical Care in Diabetes - 2017
The American Diabetes Association (ADA) has released their annual update for their Standards of Medical Care in Diabetes. This addresses psychosocial issues in all aspects of diabetes care including self-management, mental health, communication,complications, comorbidities, and life-stage considerations. [more...]

FDA Drug Safety Communication: Updated Review of Pioglitazone and Risk of Bladder Cancer
In September 2010 and June 2011, the FDA issued drug safety communications regarding the possible risk of bladder cancer with use of pioglitazone. These alerts were based on 5-year interim study results of a 10-year epidemiologic study that was conducted by the manufacturer of pioglitazone (Actos®), Takeda Pharmaceuticals. [more...]

AACE/ACE Relabels Obesity
The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) published a position statement redefining and relabeling the term obesity (defined as body mass index [BMI] ≥ 30 kg/m2) as adiposity-based chronic disease (ABCD). [more...]

FDA Drug Safety Communication: Anesthesia and Sedation
The FDA released a drug safety communication, warning of the risk of use of general anesthetic or sedation drugs in young children or pregnant women. When used for more than 3 hours, general anesthetic and sedation drugs were found to cause widespread loss of nerve cells in the brains of pregnant and young animals. [more...]

Second-Generation Antipsychotics (SGA) and Treatment-Resistant Depression
There is no consensus definition of treatment-resistant depression (TRD); however, most published definitions imply either no response or an inadequate response to appropriate therapy. [more...]

Recent FDA Approvals

December 2016 (PDF / 281KB)

New Guidelines for Peripheral Artery Disease (PAD)
The American Heart Association (AHA) and the American College of Cardiology (ACC), in collaboration with other stakeholder organizations, updated guidelines on the management of lower extremity PAD. This update supersedes recommendations in the 2005 PAD guidelines and 2011 focused update related to lower extremity PAD. [more...]

Ticagrelor (Brilinta®) versus Clopidogrel for PAD
Data from the Examining Use of Ticagrelor in Peripheral Artery Disease (EUCLID) trial were recently presented at the 2016 AHA Scientific Sessions and published online in the New England Journal of Medicine (NEJM). EUCLID compared the efficacy and safety of ticagrelor (90 mg twice daily) and clopidogrel (75 mg once daily) in 13,885 patients 50 years and older with symptomatic PAD. [more...]

Effect of Evolocumab (Repatha®) on Atherosclerosis
Results from the key GLAGOV study were presented at the AHA Scientific Sessions and published online in the Journal of the American Medical Association. [more...]

USPSTF Guidance on Statins for Primary Prevention of Cardiovascular Disease (CVD)
The U.S. Preventive Services Task Force (USPSTF) published final recommendations on the use of statins for primary prevention of CVD in adults. [more...]

New Gout Guidelines by American College of Physicians (ACP)
The ACP published new guidelines for the treatment of gout including strong recommendations with high- or moderate-quality evidence. ACP recommends the use of corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and colchicine to treat gout flares. [more...]

Recent FDA Approvals

November 2016 (PDF/256 KB)

Risk of HBV Reactivation Associated with HCV Treatment
Concern over the risk of hepatitis B virus (HBV) reactivation in patients being treated with oral direct-acting antivirals (DAA) for hepatitis C virus (HCV) infection has resulted in revisions to the HCV treatment guidelines by the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA). [more...]

AACE/ACE Updated Guidelines for Postmenopausal Osteoporosis
The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) published updated guidelines and an algorithm on the diagnosis, risk assessment, and treatment of postmenopausal osteoporosis. Recommendations for bisphosphonate holidays (a period of time when therapy is suspended) have been revised. [more...]

Non-Small Cell Lung Cancer (NSCLC): New Treatments and ICER Report
Lung cancer is the leading cause of cancer death in the United States (U.S.). Patients with NSCLC usually present with advanced disease and have poor prognosis. Advanced disease was typically treated with chemotherapy, but newer agents are available, such as tyrosine kinase inhibitors (TKIs) that focus on tumor mutations, and programmed death-1 (PD-1) immunotherapies that target substances produced by the tumor that aid its survival. [more...]

Recent FDA Approvals

October 2016 (PDF/343 KB)

Hot Topic: Biosimilar Spotlight: Fourth Biosimilar Approved
On September 23, 2016, the Food and Drug Administration (FDA) approved Amgen’s AmjevitaTM (adalimumab-atto) as a biosimilar to AbbVie’s Humira® (adalimumab) for all eligible indications of the reference product. [more...]

FDA Drug Safety Communication: Opioids and Benzodiazepines
The FDA conducted and reviewed multiple studies that found an increase in concomitant dispensing of opioids and benzodiazepines, by as much as 41% between 2002 and 2014. [more...]

CDC Updates Contraceptive Recommendations
The Centers for Disease Control and Prevention (CDC) updated their 2013 Selected Practice Recommendations for Contraceptive Use. One of the major updates includes timing to initiate routine contraception following emergency contraception use. [more...]

WHO Releases New Guidelines for Sexually Transmitted Infections
The World Health Organization (WHO) has released new guidelines for the treatment of 3 common sexually transmitted infections (STIs): chlamydia, gonorrhea, and syphilis. Resistance to these bacterial infections has recently increased leaving prescribers with reduced treatment options. [more...]

Treatment of Opioid-Use Disorders
Opioids, which are typically prescribed to treat pain, may produce feelings of euphoria, tranquility, and sedation, leading some patients to continue to take these medications longer than needed. [more...]

Barriers to Use of Long-Acting Injectable Antipsychotics
Lack of insight in schizophrenia can lead to medication nonadherence and, ultimately, relapse. In 2005, the cost of rehospitalization related to antipsychotic nonadherence in the U.S. was estimated at $1.6 billion. [more...]

Recent FDA Approvals

September 2016 (PDF/265 KB)

Hot Topic: Self-Injectable Epinephrine
Epinephrine auto-injector is indicated for the emergency treatment of type 1 allergic reactions, including anaphylaxis. The pre-filled auto-injector device allows a person experiencing a life-threatening allergic reaction, or their caregiver, to administer a fixeddose of epinephrine intramuscularly or subcutaneously (SC) into the thigh. [more...]

New Guidelines for Chronic Pain in Cancer Survivors
The American Society of Clinical Oncology (ASCO) released the first guidelines for managing chronic pain in cancer survivors. Cancer survivors may have complex pain syndromes after cancer treatment, some of which may involve chemotherapy-induced neuropathy or neuralgias. [more...]

Updated Guidelines on Aspergillosis and Coccidiodomycosis
Recently, the Infectious Diseases Society of America (IDSA) updated guidelines on the treatment of aspergillosis and coccidioidomycosis. The aspergillosis guidelines, last published in 2008, were updated with new data on new and existing therapies since the prior guideline publication, and the coccidioidomycosis guidelines include expanded recommendations for diagnosing and managing early infections. [more...]

Recent FDA Approvals

August 2016 (PDF/272 KB)

Hepatitis C: Updated Guidance and New Treatment Option
The American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) have revised their hepatitis C virus (HCV) guidelines. The update includes the addition of the new once-daily oral HCV antiviral, sofosbuvir/velpatasvir (Epclusa®; Gilead). [more...]

HHS Expands Their Fight Against the Opioid Epidemic in the U.S.
Deaths from prescription opioid overdose have dramatically risen over the past 2 decades. In March 2015, the Department of Health and Human Services (HHS) made the battle on opioid abuse and addiction a priority by launching their Opioid Initiative with goals to decrease opioid use disorder, overdose, and opiod-related mortality. [more...]

Updated Guidance for the Use of Antiretrovirals to Treat HIV/AIDs
The Department of Health and Human Services has updated their guidelines for antiretroviral therapy (ART) in HIV-1-infected adults and adolescents. Key updates in the "What to Start" section include the addition of tenofovir alafenamide (TAF)-containing products as first-line options in combination with dolutegravir, darunavir/ritonavor or raltegravir for ART-naïve patients with more favorable adverse events than tenofovir disoproxol fumurate (TDF) on bone and renal health. [more...]

Cardiovascular Problems with Abuse and Misuse of Loperamide
The FDA has warned that higher than recommended doses of the antidiarrheal medicine loperamide, available with and without (Imodium A-D®) a prescription, can lead to serious cardiovascular (CV) adverse events, including arrhythmias and CV death. [more...]

Voluntary Recall of Docusate Sodium Oral Liquid
The FDA and the Center for Disease Control and Prevention (CDC) informed the public of a voluntary recall of oral liquid formulations of the OTC stool softener, docusate sodium, due to a multistate outbreak of Burkholderia cepacia infection. B. cepacia can result in serious respiratory infections in patients who are immunocompromised or with chronic lung conditions, such as cystic fibrosis (CF). [more...]

Recent FDA Approvals

July 2016 (PDF/410 KB)

FDA Approves Epclusa®: First Pangenotypic Agent to Treat Chronic Hepatitis C Virus (HCV)
On June 28, 2016, under a priority review, the Food and Drug Administration (FDA) approved the first pangenotypic oral direct-acting antiviral agent to treat chronic HCV infection, targeting genotypes 1-6. Approximately 70-75% of people infected with HCV in the United States (U.S.) have genotype 1; about 15-20% have genotype 2; and 10-12% are infected with genotype 3. [more...]

LEADER Trial Reports Cardiovascular Outcomes of Liraglutide
Type 2 diabetes is associated with a high risk of cardiovascular (CV) complications. Studies have confirmed that glycemic control leads to decreased risk of microvascular complications; however, the same has not been proven regarding macrovascular risks, such as CV disease. [more...]

Focused Guidelines for the Treatment of Heart Failure
The American College of Cardiology (ACC) along with the American Heart Association (AHA) and the Heart Failure Society of America (HFSA) published a focused guideline on new pharmacologic therapy for HF, which is an update to the 2013 American College of Cardiology Foundation (ACCF)/AHA guideline on the management of HF. [more...]

FDA Strengthens Warnings for Canagliflozin and Dapagliflozin
The FDA strengthened existing warnings for antidiabetic agents containing the SGLT2 inhibitors canagliflozin (Invokana®, Invokamet®) or dapagliflozin (Farxiga®, Xigduo XR®) regarding the risk of acute kidney injury. [more...]

Smartphones for Bipolar Disorder Monitoring
Bipolar disorder has a recurrent and chronic nature that results in impaired functioning of daily life. [more...]

New Guidance on the Management of Chronic Insomnia
Approximately 6-10% of adults suffer from insomnia, particularly women and older adults. Treatments include psychological and pharmacological therapies, or a combination of both. [more...]

Recent FDA Approvals

June 2016 (PDF/263 KB)

Restricted Use of Fluoroquinolone Antibiotics
The Food and Drug Administration (FDA) has strengthened its warnings for the use of systemic fluoroquinolone antibiotics (e.g., oral and injectable formulations). [more...]

New Guidance on Cystic Fibrosis Treatment in Preschoolers
The Cystic Fibrosis Foundation released practice guidelines for the treatment of cystic fibrosis (CF) in preschool aged children, closing the guideline gap for patients ages 2 to 5 years. [more...]

Potential Increased Risk of Amputation Associated with Canagliflozin
The FDA has alerted the public of interim results from the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) that found an increase in leg and foot amputations (mostly of the toes) in diabetic patients treated with canagliflozin (Invokana®, Invokamet®), a sodium-glucose cotransporter-2 (SGLT2) inhibitor. [more...]

CDC Update on HIV Postexposure Prophylaxis
The Centers for Disease Control and Prevention (CDC) released updated guidelines for antiretroviral (ARV) postexposure prophylaxis after nonoccupational exposure to HIV (e.g., sexual, injection-drug use), also known as nPEP. [more...]

USPSTF Issues New Recommendation on Aspirin Therapy
The U.S. Preventive Services Task Force (USPSTF) recommends initiating low-dose aspirin therapy for the primary prevention of cardiovascular disease (CVD) and colorectal cancer (CRC) in adults 50 to 59 years old with a 10-year CVD risk ≥ 10% who are not at a high risk for bleeding, willing to take low-dose aspirin, and with a life expectancy of at least 10 years. [more...]

Olanzapine Use Associated with Rare Skin Reaction
The FDA issued a warning that the use of antipsychotic medications containing olanzapine (Zyprexa®, Symbyax®) can result in the rare but serious condition, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). [more...]

May 2016 (PDF/306 KB)

Hot Topic: FDA Approves First Biosimilar Monoclonal Antibody, Infliximab-dyyb (Inflectra™)
On April 5, the Food and Drug Administration (FDA) approved the first monoclonal antibody, infliximab-dyyb (Inflectra) by Celltrion/Pfizer, as a biosimilar to Janssen’s infliximab (Remicade®). [more...]

Dual Antiplatelet Therapy (DAPT) Recommendations
In late March, the American College of Cardiology (ACC) and American Heart Association (AHA) released a focused update on DAPT in patients with coronary artery disease. [more...]

ACC Decision Pathway for Non-Statin Therapies
The ACC released a decision pathway for clinicians and patients looking for further guidance on the use of non-statin therapy in patients treated with statins who require additional low-density lipoprotein cholesterol (LDL-C) lowering to manage atherosclerotic cardiovascular disease (ASCVD). [more...]

Recent FDA Approvals

April 2016 (PDF/331 KB)

CDC Releases Opioid Prescribing Guideline
The United States is experiencing an opioid epidemic, with prescription opioids at its center. It is estimated that 20% of patients assessed by physicians for acute or chronic noncancer-related pain are prescribed an opioid agent. [more...]

FDA Efforts to Decrease Opioid Abuse and Improve Safety of Use
In a response to the opioid abuse epidemic, the FDA announced its strategy to assess their approach to opioid medications. [more...]

NIH Strategy for Improving Pain Control
The National Institute of Health’s (NIH) Interagency Pain Research Coordinating Committee created a National Pain Strategy (NPS) that outlines a plan to reduce the burden of chronic pain in the United States. [more...]

Mortality Risk for Antipsychotic Use with Parkinson’s Disease
In recent years, the FDA has issued warnings that the treatment of behavioral disorders in elderly patients with dementia with first- and second-generation antipsychotic (FGA, SGA) medications is associated with increased mortality. [more...]

Non-Standard Treatments for First-Episode Schizophrenia
First-episode psychosis (FEP) in schizophrenia often responds well initially to antipsychotic (AP) therapy; however, this has found to be followed by drug discontinuation and relapse during maintenance treatment. [more...]

Recent FDA Approvals

March 2016 (PDF/204 KB)

Updated Guidance for Hepatitis C Virus (HCV) and Expanded Indications
The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) updated their guidance on the management of HCV infection. [more...]

Increased Risk of Dementia Associated with Proton Pump Inhibitors
A large observational study identified a link between the use of proton pump inhibitors (PPIs) and an increased risk of dementia in the elderly. PPIs, such as esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole, are widely used to treat upper gastrointestinal tract acid-related disorders such as gastroesophageal reflux disease (GERD) and gastric ulcers. [more...]

Appropriate Antibiotic Use for Respiratory Tract Infections
Acute respiratory tract infection (ARTI) results in more outpatient physician visits and antibiotic prescriptions than any other condition. Antibiotics are often prescribed inappropriately for ARTI contributing to antibiotic resistance, medication-related adverse events, and excess costs. [more...]

Benefits and Risks of Long-Term Bisphosphonate Therapy
An American Society for Bone and Mineral Research (ASBMR) task force has provided guidance regarding bisphosphonate (BP) therapy duration for patients with osteoporosis. [more...]

Recent FDA Approvals

February 2016 (PDF/231 KB)

Merck’s Zepatier™ Approved for Treatment of Hepatitis C
On January 28, 2016 the Food and Drug Administration (FDA) approved Merck’s hepatitis C antiviral, Zepatier, a once-daily, single-tablet combination therapy consisting of elbasvir, an NS5A inhibitor, and grazoprevir, an NS3/4A protease inhibitor, to be used with or without ribavirin (RBV) for the treatment of adults with chronic hepatitis C virus (HCV) genotypes 1 or 4 infection. [more...]

Updated Guidelines for Treatment of VTE
The Antithrombotic Therapy for Venous Thromboembolism (VTE) Disease CHEST Guideline from the American College of Chest Physicians (ACCP) was updated in January 2016 in an effort to address new evidence in the treatment of VTE. [more...]

AACE/ACE Guidance for Type 2 Diabetes Management
The American Association of Clinical Endocrinologists (AACE) and American College of Endocrinologists (ACE) have published an update to their 2015 Comprehensive Diabetes Management Algorithm and Executive Summary for Type 2 Diabetes (T2D). [more...]

Recent FDA Approvals

January 2016 (PDF/350 KB)

New ACR Guidelines for Rheumatoid Arthritis
Due to the rapid accrual of new evidence in the area of rheumatoid arthritis (RA), as well as the development of new therapies since their last guideline update in 2012, the American College of Rheumatology (ACR) developed new 2015 guidelines on the pharmacologic treatment of RA. [more...]

ACG Guidelines on Barrett’s Esophagus
The American College of Gastroenterology (ACG) updated their guidelines on the diagnosis and management of Barrett’s esophagus (BE), a complication of gastroesophageal reflux disease (GERD) and a potential precursor to esophageal adenocarcinoma. [more...]

First Practice Guidelines for Ankylosing Spondylitis
The first guidelines for the treatment of ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (SpA) were published by the American College of Rheumatology (ACR). [more...]

HHS Panel Recommendation for Fixed Dose Combination Product
The fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (EVG/c/FTC/TAF; Genvoya®) was FDA approved in November 2015 for treatment of HIV-1 infection in patients 12 years of age and older with an estimated creatinine clearance (CrCl) of ≥ 30 mL/min who are antiretroviral therapy (ART) naïve and in select ART-experienced patients. [more...]

ASCO Antiemetic Focused Guideline Update
The American Society of Clinical Oncology (ASCO) guideline for the use of antiemetics was first published in 1999 with the most recent full update in 2011. [more...]

Clozapine versus Standard Antipsychotics for Schizophrenia
Clozapine remains the only medication approved for treatment-resistant schizophrenia. Clinical trials have demonstrated its efficacy in prolonging time to treatment discontinuation. [more...]

Screening of Antipsychotic Side Effects via Telemental Health
All antipsychotic medications may cause movement disorders. Acute movement disorders, such as parkinsonism, akathisia, and dystonia, may occur shortly after an antipsychotic medication is initiated and is often short lived. [more...]

Recent FDA Approvals

 December 2015 (PDF/256 KB)

AHA Scientific Statement for Familial Hypercholesterolemia
The American Heart Association (AHA) published a scientific statement for the diagnosis and treatment of familial hypercholesterolemia (FH), a rare genetic disorder that leads to severely increased levels of low-density lipoprotein cholesterol (LDL-C) in the blood and premature atherosclerotic cardiovascular disease (CVD). [more...]

Final Report on PCSK9 Inhibitors by ICER
The Institute for Clinical and Economic Review (ICER) has posted the final report, PCSK9 Inhibitors for Treatment of High Cholesterol: Effectiveness, Value, and Value-Based Price Benchmarks, along with action guidelines. [more...]

FDA Approves First Intranasal Naloxone for Opioid Overdose
The FDA granted fast-track designation and priority review to the first naloxone nasal spray (Narcan® nasal spray; Adapt) for the emergency treatment of known or suspected opioid overdose, which may be administered by a friend, family member, caregiver, first responder, or healthcare provider (HCP). [more...]

First Guidelines for Pediatric Pulmonary Hypertension
The American Heart Association (AHA) and the American Thoracic Society (ATS) published the first consensus guidelines for the management of pediatric pulmonary hypertension (PH), which affects nearly 1 in 500 infants born each year. [more...]

FDA Grants Expanded Indication for Harvoni®
Gilead’s ledipasvir-sofosbuvir (Harvoni) has gained new indications to include patients with chronic hepatitis C virus (HCV) genotype 4, 5, and 6 infections and patients co-infected with the human immunodeficiency virus-1 (HIV-1). [more...]

Recent FDA Approvals

November 2015 (PDF/393 KB)

Liver Injury Reported with Viekira Pak™ and Technivie™
The Food and Drug Administration (FDA) is warning that Abbvie’s fixed-dose combination hepatitis C antiviral agents, ombitasvir-paritaprevir-ritonavir plus dasabuvir (Viekira Pak) and ombitasvir-paritaprevir-ritonavir (Technivie), may cause serious liver injury. [more...]

First Reversal Agent for Pradaxa® is FDA Approved
The FDA has approved Boehringer Ingelheim’s (BI) idarucizumab (Praxbind®) as a breakthrough therapy for use in patients treated with dabigatran (Pradaxa; BI) who require reversal of the anticoagulant effects of dabigatran when emergency surgery or an urgent procedure is needed and in cases of life-threatening or uncontrolled bleeding. [more...]

Auvi-Q® Voluntary Recall
Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection) due to the potential for inaccurate dosage delivery. [more...]

FDA Approves Olysio® for Hepatitis C Genotype 4
The FDA expanded the indication for simeprevir (Olysio; Janssen) to include treatment of chronic hepatitis C virus (HCV) genotype 4 infection, in addition to the existing HCV genotype 1 indication. [more...]

AASLD Guidance Update on When and in Whom to Initiate HCV Therapy
Based on greater real-world experience of the efficacy and tolerability of direct-acting antiviral (DAA) agents to treat chronic HCV infection and increased data on the benefits of treatment during all stages of the disease, the AASLD/IDSA panel recommends treatment for nearly all patients with chronic HCV; they no longer prioritize treatment to those with the greatest need, such as individuals with severe liver disease. [more...]

World Health Organization Offers Guidance on When to Start ART and PrEP for HIV
In an early-release guideline, the World Health Organization (WHO) has removed all limitations on eligibility for antiretroviral therapy (ART) for patients with HIV-1 infection. [more...]

Recent FDA Approvals

October 2015  (PDF/679 KB)

Daraprim® for Toxoplasmosis Pyrimethamine (Daraprim; Turing Pharmaceuticals) is an oral antiparasitic agent indicated to treat toxoplasmosis gondii and prevent and treat acute malaria. [more...]

AASLD Overview of Cost Considerations for HCV
In the quickly changing field of antiviral therapy for hepatitis C virus (HCV), one of the most common challenges is access to care due to high drug cost. [more...]

FDA Safety Communication for Clozapine Related Neutropenia
The Food and Drug Administration (FDA) has changed the requirements for monitoring, prescribing, and dispensing of the atypical antipsychotic agent, clozapine, in order to reflect current knowledge of safety concerns regarding neutropenia. [more...]

Cardiovascular Outcomes for Empagliflozin
The EMPA-REG OUTCOME trial was a placebo-controlled, double-blind trial designed to determine non-inferiority of empagliflozin (Jardiance® Boehringer Ingelheim) compared to placebo on CV morbidity and mortality in patients with type 2 diabetes (T2DM) who were at high risk for CV events. [more...]

FDA Safety Warning: Bone Fracture linked to Canagliflozin Use
The FDA strengthened the warning for the SGLT2 inhibitor canagliflozin (Invokana®, Invokamet® Janssen) related to the increased risk of bone fractures and added new information to the drug label about decreased bone mineral density (BMD). [more...]

AHA Discusses MDD/Bipolar Disorder CVD Risk in Adolescents
Major depressive disorder (MDD) and bipolar disorder (BD) together affect about 10% of adolescents in the U.S. In 2011, the American Heart Association (AHA) identified several medical conditions that put this population at moderate to high risk for early cardiovascular disease (CVD). [more...]

Injectable Risperidone for Recent Onset Schizophrenia 

Schizophrenia has been historically difficult to treat; with several studies demonstrating that nonadherence to medications contributes to the return of psychotic symptoms and relapse. [more...]

Recent FDA Approvals



September 2015    (PDF/210 KB)                                                        


FDA Approves Second PCSK9 Inhibitor for Hyperlipidemia
Amgen’s evolocumab (Repatha™) has received Food and Drug Administration (FDA) approval as adjunct therapy to diet and maximally tolerated statins in adults with clinical atherosclerotic cardiovascular disease (CVD), heterozygous familial hypercholesterolemia (HeFH), or homozygous familial hypercholesterolemia (HoFH), who require additional lowering of low density lipoprotein cholesterol (LDL-C). [more...]

First Drug Utilizing 3D Printing Technology is FDA Approved On July 31, 2015, the FDA approved Aprecia Pharmaceuticals’ antiseizure agent, levetiracetam (Spritam®), marking the first approval of a drug utilizing three-dimensional printing (3DP) technology. [more...] 

The Pink Pill gets FDA Approval for Sexual Dysfunction in Women
Sexual dysfunction affects approximately 10% of women in the United States. Sprout Pharmaceuticals’ flibanserin (Addyi™) was granted approval for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, the most common form of female sexual dysfunction. [more...]

Recent FDA Approvals

 August 2015  (PDF/233 KB)
Hot Topic: PCSK9 Inhibitor Spotlight
The Food and Drug Administration (FDA) has approved, alirocumab (Praluent® Regeneron/Sanofi), the first agent in a new class of drugs to treat hyperlipidemia. [more...]
What’s New with Hepatitis C Virus (HCV)
The FDA approved the first drugs to treat chronic HCV genotypes 3 and 4 infections as part of ribavirin-free and/or interferon-free therapies. [more...]
ASCO Guidelines for the Use of White Blood Cell (WBC) Growth Factors
The American Society of Clinical Oncology (ASCO) published an update to its 2006 clinical practice guidelines on the use of white blood cell (WBC) growth factors (a.k.a hematopoietic colony-stimulating factors [CSF]). [more...]
Recent FDA Approvals
July 2015  (PDF/293 KB)

CDC Updates STD Treatment Guidelines The Center for Disease Control and Prevention (CDC) has updated its 2010 guidelines for the prevention and treatment of sexually transmitted diseases (STDs). [more...]

FDA Safety Alert: Daytrana® and Skin Color Changes
The Food and Drug Administration (FDA) has alerted the public that permanent loss of skin color, also known as chemical leukoderma, may occur with the use of methylphenidate transdermal patch (Daytrana®), a central nervous system (CNS) stimulant used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. [more...]

FDA Approves Two Agents for Irritable Bowel Syndrome
Irritable bowel syndrome with diarrhea (IBS-D) affects up to 15 million people in the U.S. It is a functional bowel disorder characterized by chronic, sometimes debilitating, abdominal pain and frequent diarrhea. [more...]

IMPROVE-IT: The Addition of Ezetimibe to Simvastatin on Cardiovascular Risk
The placebo-controlled Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) evaluated the cardiovascular (CV) effect of adding ezetimibe (Zetia®) to moderate doses of simvastatin (Zocor®). [more...]
Smoking and Schizophrenia: A Swedish Prospective Study
There is a strong association between smoking and schizophrenia; however, the causal relationship is unknown. [more...]
Antipsychotic Drug Use During Pregnancy
Antipsychotic drug use during pregnancy is on the rise; however, data concerning the effects of the newer atypical antipsychotics on maternal and perinatal health outcomes are lacking. [more...]
Recent FDA Approvals
June 2015   (PDF/304 KB)
FDA Panel Recommends Cardiovascular Warning for the DPP-4 Inhibitors, Saxagliptin and Alogliptin
Diabetes mellitus affects approximately 29 million people in the United States. People with diabetes are at increased risk for cardiovascular (CV) disease. [more...]
FDA MedWatch: SGLT-2 Inhibitors
The FDA issued a drug safety communication on May 15, 2015, warning that the sodium-glucose cotransporter-2 (SGLT2) inhibitors used to treat type 2 diabetes, canagliflozin (Invokana®; Janssen), dapagliflozin (Farxiga®; AstraZeneca), and empagliflozin (Jardiance®; Boehringer Ingelheim), may lead to ketoacidosis. [more...]
American Academy of Pediatrics Treatment Guidelines for Head Lice
The American Academy of Pediatrics (AAP) released an update to the 2010 clinical report on the treatment of head lice which provides information to healthcare providers on the safe and effective treatment of head lice, including information on new products. [more...]
Management of First Seizure in Adults
The American Academy of Neurology (AAN) and the American Epilepsy Society (AES) released evidence-based guidelines on the prognosis and treatment of a first unprovoked seizure in adults. [more...]
Digoxin-associated Mortality Risk
Digoxin has been used for many years for the treatment of congestive heart failure (CHF) and atrial fibrillation (AF); however, conflicting data exist on the effect of digoxin use on the mortality of patients with CHF and/or AF. [more...]
Recent FDA Approvals
May 2015   (PDF/527 KB)
Recent Outbreak of HIV and HCV Infections with Injection Drug Use
The Indiana State Department of Health (ISDH) and the Centers for Disease Control and Prevention (CDC) revealed a recent and rapid spread of human immmunodeficiency virus (HIV) infection in a small rural community in Indiana. [more...]
FDAs Final Industry Guidance on Abuse-Deterrent Opioids
Abuse and misuse of opioid medications is a serious and growing public health concern and the FDA considers the development of abuse-deterrent products a high priority. [more...]
Updated Guidelines for the Use of ART in Adults and Adolescents
On April 8, 2015, the Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents released updated Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. [more...]
Recent FDA Approvals
 April 2015    (PDF/281 KB)
FDA Approves First Biosimilar Product
The Food and Drug Administration (FDA) has approved the first biosimilar product in the United States. Filgrastim-sndz (Zarxio™; Sandoz) was approved as a biosimilar to filgrastim (Neupogen®; Amgen), which was originally approved by the FDA in 1991. [more...]
Updated Guidelines for ART in Pediatrics with HIV Infection
The Department of Health and Human Services (HHS) Panel on Antiretroviral Therapy (ART) and Medical Management of HIV-Infected Children released updated Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. [more...]
CTAF Final Report for Combination Hepatitis C Virus Therapy
The California Technology Assessment Forum (CTAF) reviews evidence reports and provides a public venue to discuss the evidence on the effectiveness and value of health care services. [more...]
Harvoni for Hepatitis C in HCV/HIV Co-infected patients
Ledipasvir/sofosbuvir (Harvoni; Gilead) is a fixed-dose combination of an HCV NS5A inhibitor and an HCV nucleotide analog NS5B polymerase inhibitor indicated for the treatment of adults with chronic HCV genotype 1 infection. [more...]
Perspectives on Reasons for Psychiatric Medication Non-Adherence
The World Health Organization has reported the ratio of medication adherence of approximately 50% in individuals with chronic diseases. [more...]
Translocator Protein Density and Major Depression
A link between individuals suffering from major depressive episodes (MDE) and brain inflammation was reported in a recent study published in the Journal of the American Medical Association Psychiatry. [more...]
Recent FDA Approvals
March 2015   (PDF/579 KB)
New Report of PML with Fingolimod (Gilenya®)
The second occurrence of progressive multifocal leukoencephalopathy (PML) has been reported in a patient who had received oral fingolimod (Gilenya®; Novartis) for the treatment of relapsing multiple sclerosis (MS). [more...]
American Academy of Ophthalmology Offers Tips on Glaucoma Treatment Adherence
Glaucoma is the leading cause of irreversible blindness in the United States (US); however, when treated early, vision loss can be prevented. [more...]
FDA Guidance on Direct-to-Consumer Printed Advertisements
The FDA oversees the labeling and advertising of prescription drugs. The agency recently issued revised draft guidance to their 2004 Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements. [more...]
FDA Draft Guidance for Compounding of Human Drugs
In November 2013, as a response to contaminated compounded drug products that led to deaths from fungal meningitis, Congress enacted the Drug Quality and Security Act (DQSA) and created the new Section 503B of the federal Food, Drug, and Cosmetic (FD&C) Act. [more...]
Recent FDA Approvals
February 2015 (PDF/249 KB)
Hot Topic: AASLD/IDSA Chronic Hepatitis C Guidance Updates
During the 4th quarter of 2014, there were multiple rulings by the Food and Drug Administration (FDA) that brought about new therapies for the treatment of chronic hepatitis C and new indications for previously approved medications. [more...]
Centers for Disease Control and Prevention (CDC) Health Update: Use of Influenza Antivirals
Influenza activity is high across the U.S. this season, with most states reporting widespread activity, with influenza A (H3N2) viruses most common. [more...]
FDA Drug Safety Update: Pain Medications During Pregnancy
Prescription and over-the-counter (OTC) medications for the treatment of pain are often used during pregnancy, including non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and opioids. [more...]
American Diabetes Association (ADA) Issues 2015 Standards of Medical Care in Diabetes
In January 2015, the ADA issued their Standards of Medical Care in Diabetes. The purpose of these guidelines is to provide clinicians, patients, researchers, payers, and others with components of diabetes care, general treatment goals, and tools to evaluate the quality of care. [more...]
Recent FDA Approvals
January 2015   (PDF/618 KB)
Hot Topic: Hepatitis C Spotlight
The Food and Drug Administration (FDA) approved AbbVie’s ombitasvir, paritaprevir, and ritonavir fixed-dose combination tablets co-packaged with dasabuvir tablets (Viekira Pak™), for the treatment of patients with chronic hepatitis C virus (HCV) genotype (GT) 1 infection, including patients with cirrhosis. [more...]
Health and Human Service Guidelines for HIV/Hepatitis C Co-Infection
The Department of Health and Human Services (HHS) has updated their Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents. [more...]
Center for Disease Control and Prevention Guidance on HIV Prevention
The Centers for Disease Control and Prevention (CDC) released new guidelines for HIV Prevention with Adults and Adolescents with HIV in the U.S as an update to their 2003 Recommendations for Incorporating HIV Prevention into the Medical Care of Persons Living with HIV guidelines. [more...] 
FDA Releases Final Rule on Pregnancy and Lactation Labeling
The FDA published a final rule requiring labeling changes for prescription drugs and biological agents regarding their use during pregnancy and lactation. [more...]
Antidepressants and Cognitive Decline in Older Adults with a History of Major Depression
Older patients with Major Depressive Disorder (MDD) often present with cognitive impairment to a greater extent than patients of similar age and education without a history of MDD. [more...]
The Relationship between Syncope, Depression and Antidepressant Use in the Elderly
Syncope is defined as a sudden loss of consciousness associated with the inability to maintain postural tone followed by spontaneous recovery. [more...]
Recent FDA Approvals
December 2014  (PDF/234 KB)

Hot Topic: Hepatitis C Spotlight

The Food and Drug Administration (FDA) has approved Janssen’s simeprevir (Olysio®) to be used in combination with Gilead’s sofosbuvir (Sovaldi®) as an all oral, interferon- and ribavirin-free option for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection in adults. [more...]

AASLD/IDSA Statement on Treating Chronic HCV

In September 2014, the AASLD/IDSA updated their guidelines for the treatment of chronic HCV infection to include the new section When and in Whom to Initiate HCV Therapy, which provides guidance to identify patients with chronic HCV infection in immediate need of treatment and those who can safely wait for drugs in the pipeline to become available. [more...]

American Heart Association (AHA) Primary Prevention of Stroke Guidelines Stroke ranks as the fourth-leading cause of death in the United States and the leading cause of functional impairment. [more...]

Recent FDA Approvals 


November 2014  (PDF/204 KB)

Hot Topic: Hepatitis C Spotlight 

On October 10, 2014, the Food and Drug Administration (FDA) approved Gilead’s fixed-dose combination ledipasvir/sofosbuvir (Harvoni®). [more...]

AASLD Guidelines for the Management of Acute HCV Infection 

The American Association for the Study of Liver Diseases (AASLD) has published recommendations for managing acute HCV infection. [more...]

DEA Provides More Options for Prescription Drug Disposal

In an effort to reduce stockpiles of unwanted or unused medicines in homes, the Drug Enforcement Agency (DEA) has sponsored bi-annual nationwide medication take-back events, collecting over 2,100 tons of medication at over 6,000 sites. [more...]

FDA Purple Book

The FDA has introduced the List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, also known as the Purple Book. [more...]

Recent FDA Approvals [more...]

October 2014   (PDF/365 KB)

Updated Group A Streptococcal Pharyngitis Diagnosis and Treatment Guidelines The Infectious Diseases Society of America (IDSA) updated their 2002 clinical practice guidelines for the diagnosis and management of Group A streptococcal (GAS) pharyngitis. [more...]

Updated Guidelines for Hepatitis C Testing The Centers for Disease Control (CDC) has expanded their previous recommendations for the hepatitis C virus (HCV) testing target population to include baby boomers. [more...]

Possible Risk of Heart Failure Associated with pramipexole (Mirapex®) The Food and Drug Administration (FDA) announced an ongoing safety review of the possible risk of heart failure in patients treated with pramipexole (Mirapex). [more...]

Hydroxyprogesterone Caproate A hearing was held in a US District Court on August 7, 2012, in the lawsuit filed by KV Pharmaceuticals versus FDA and Health and Human Services (HHS) (collectively FDA) over hydroxyprogesterone caproate (Makena™) exclusivity. [more...]

Product Discontinuations Buprenorphine and naloxone (Suboxone®) Sublingual (SL) Tablets and Albuterol inhalation Solution (AccuNeb®) [more...]

FDA Approved New Molecular Entities (NMEs), Biologic Products (BLAs)/Orphan Drugs and New Indications/New Formulations for Existing Products [more...]

September 2014  (PDF/365 KB)

Influenza (flu) Vaccine The 2012–2013 flu vaccine formulation for all six manufacturers licensed to produce and distribute the vaccines in the United States has received Food and Drug Administration (FDA) approval. [more...]

Codeine Safety FDA has issued a safety communication regarding codeine for children who have undergone tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. [more...]

Unstable Angina (UA)/Non-ST-Elevation Myocardial Infarction (NSTEMI) Clinical Guidelines American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) have updated their UA/NSTEMI guidelines and added ticagrelor (Brilinta®) with a class I recommendation. [more...]

Gonorrhea Evidence-Based Practice Guidelines Recent data from CDC's Gonococcal Isolate Surveillance Project have shown development of resistance for Neisseria gonorrhoeae to the oral antibiotic cefixime. [more...]

Hydroxyprogesterone Caproate A hearing was held in a US District Court on August 7, 2012, in the lawsuit filed by KV Pharmaceuticals versus FDA and HHS (collectively FDA) over hydroxyprogesterone caproate (Makena™) exclusivity. [more...]

FDA Approved New Molecular Entities (NMEs), Biologic Products (BLAs)/Orphan Drugs and New Indications/New Formulations for Existing Products [more...]

August 2014 (PDF / 245 KB)

Updated Synagis® Guidelines for RSV Prophylaxis
The American Academy of Pediatrics (AAP) has updated its guidelines for the use of palivizumab (Synagis) for the prophylaxis of respiratory syncytial virus (RSV) infection in infants and young children. [more...]

International Antiviral Society-USA Updated HIV Clinical Practice Guidelines
The International Antiviral Society-USA (IAS-USA) published updated guidelines for the antiretroviral treatment (ART) of HIV infection in adults. Since early initiation of ART reduces the likelihood of HIV transmission while providing clinical benefit, IAS-USA advises to start ART as soon as possible after diagnosis, regardless of CD4 cell count. [more...]

Drug Information Highlights
The Drug Enforcement Administration (DEA) announced that, effective August 18, 2014, tramadol will be assigned a schedule IV controlled substances status. [more...]

Recent FDA Approvals

July 2014 (PDF / 195 KB)

PINNACLE Registry Reports One in Five Patients on Prasugrel (Effient®) for Inappropriate Indication
The PINNACLE Registry®, the largest outpatient cardiovascular (CV) data repository in the U.S., aids in identifying CV practice patterns. [more...]

Afrezza®, an Inhaled Insulin, Approved for Type 1 and Type 2 Diabetes
MannKind has received approval for Afrezza®, insulin human inhalation powder, a rapid-acting insulin to treat adults with diabetes. [more...]

American Diabetes Association (ADA) Updates Blood Sugar Targets for Pediatric Patients with Type 1 Diabetes
Each year, an estimated 18,000 children and adolescents in the U.S. are diagnosed with type 1 diabetes (T1DM), characterized by immune-mediated ß-cell destruction and the need for lifelong insulin therapy. [more...]

The Center for Disease Control and Prevention’s (CDC) Advisory Panel Prefers Flu Nasal Spray over Flu Shots
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend the live attenuated influenza vaccine nasal spray (FluMist®) over the flu shot for the prevention of influenza in healthy children ages two to eight years. [more...]

FDA Approved New Molecular Entities (NMEs), Biologic Products (BLAs)/Orphan Drugs and New Indications/New Formulations for Existing Products

June 2014 (PDF / 205 KB)

Hepatitis C Virus (HCV) Hot Topic: Medicaid Report
The Medicaid Evidence Based Decisions Project (MED), based at the Center for Evidence-Based Policy at Oregon Health and Science University (OHSU), has released a report titled, Sofosbuvir for the Treatment of Hepatitis C and Evaluation of the 2014 American Association for the Study of Liver Diseases Treatment Guidelines. [more...]

Guideline Focus: Breast Cancer Updated Clinical Practice Guidelines
The American Society of Clinical Oncology (ASCO) has published a focused update to reflect emerging evidence on duration of tamoxifen treatment in patients with hormone receptor (HR) positive breast cancer, the most common type of breast cancer in women. [more...]

Nexium® – Over-the-Counter (OTC) and Generic
As expected, on May 27th, Pfizer launched OTC Nexium® 24 Hour 20 mg delayed-release (DR) capsules for the treatment of frequent heartburn in adults ≥ 18 years old. [more...]

FDA Approved New Molecular Entities (NMEs), Biologic Products (BLAs)/Orphan Drugs and New Indications/New Formulations for Existing Products

May 2014 (PDF / 201 KB)

Hepatitis C Virus (HCV) Hot Topic: International Guidance
In conjunction with the International Liver Congress, the European Association for the Study of the Liver (EASL) and the World Health Organization (WHO) have released HCV guidance. [more...]

Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis
The federal government (Departments of Health and Human Services [HHS], Housing and Urban Development [HUD], Justice [DOJ], and Veterans Affairs [VA]) has released a three-year update of its viral hepatitis action plan for the prevention, care, and treatment of viral hepatitis. [more...]

Guidelines Focus: American Heart Association (AHA), American College of Cardiology (ACC), Heart Rhythm Society (HRS) Updated Atrial Fibrillation Guidelines
The AHA/ACC/HRS has released updated guidelines for the management of patients with atrial fibrillation. [more...]

Hereditary Angioedema (HAE): Pediatric Age Expansion
Ecallantide (Kalbitor®), a plasma kallikrein inhibitor, is now indicated for acute attacks of HAE in ages = 12 years old. [more...]

FDA Approved New Molecular Entities (NMEs), Biologic Products (BLAs)/Orphan Drugs and New Indications/New Formulations for Existing Products

April 2014 (PDF / 177 KB)

California Technology Assessment Forum℠ (CTAF): Hepatitis C New Treatment Draft Assessment Report
The CTAF is a nationally-recognized patient-centered forum dedicated to objectivity and transparency. [more...]

Guidelines Focus: American Academy of Neurology (AAN) Updated Guidelines for Stroke Prevention
In February 2014, the AAN released updated “Guidelines for Stroke Prevention” in patients with nonvalvular atrial fibrillation (NVAF). [more...]

Voluntary Drug Recalls
Pfizer voluntarily recalled two lots of Effexor XR® 150 mg capsules and one lot of venlafaxine ER 150 mg capsules. [more...]

FDA Approved New Molecular Entities (NMEs), Biologic Products (BLAs)/Orphan Drugs and New Indications/New Formulations for Existing Products

March 2014 (PDF / 195 KB)

Hot Topic: Hepatitis C Guidelines
Chronic hepatitis C (CHC) is a blood-borne infectious viral disease of the liver that affects 3 to 4 million people in the U.S. and about 170 million people worldwide. [more...]

FDA Approved New Molecular Entities (NMEs), Biologic Products (BLAs)/Orphan Drugs and New Indications/New Formulations for Existing Products

February 2014 (PDF / 386 KB)

Evidence-Based Guidelines Focus: The Much Anticipated JNC 8 Hypertension Guidelines
The Eighth Joint National Committee (JNC 8) has independently published an update to the 2003 JNC 7 practice guideline for the management of high blood pressure (BP) in adults, based on a systematic review of randomized controlled trials. [more...]

Food and Drug Administration (FDA) Restricting Maximum Acetaminophen (APAP) Dosage Per Unit
In January 2011, the FDA recommended that manufacturers of prescription combination drug products containing APAP limit the amount to no more than 325 mg in each tablet or capsule by January 14, 2014, since risks of liver injury outweigh the benefit. [more...]

FDA Approved New Molecular Entities (NMEs), Biologic Products (BLAs)/Orphan Drugs and New Indications/New Formulations for Existing Products

 January 2014 (PDF / 192 KB)

Hot Topic: Hepatitis C Spotlight
Chronic hepatitis C (CHC) is a blood-borne infectious viral disease of the liver that affects about 3.2 million people in the U.S. and about 170 million people worldwide. [more...]

2013 New Molecular Entities (NMEs) Approved by the FDA
The FDA has approved 26 NMEs so far in 2013, compared to 35 in 2012, but there were fewer NME applications with same-year decision dates this year than last. [more...]

FDA Approved New Molecular Entities (NMEs), Biologic Products (BLAs)/Orphan Drugs and New Indications/New Formulations for Existing Products