RxStrategies Clinical Insights – September 2014, Issue 2

    Welcome to this month’s second edition of RxStrategies Clinical Insights, a concise communication to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place. 


    New Drug Approvals

    Trulicity (dulaglutide) – New Drug Approval
    September 18, 2014 – The U.S. Food and Drug Administration approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes. Read More>

    Movantik(naloxegol) – New Drug Approval
    September 16, 2014 – The U.S. Food and Drug Administration approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain. Read More>


    New Drug Indications

    Otezla® (apremilast) – New Indication
    September 23, 2014Celgene Corporation announced that the U.S. Food and Drug Administration has approved Otezla® (apremilast), a selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Read More>

    Humira® (adalimumab) – New Indication
    September 25, 2014 – AbbVie announced that the U.S. Food and Drug Administration has approved Humira® (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn’s disease patients 6 years of age and older when certain other treatments have not worked well enough. Read More>

    Xtandi® (enzalutamide) – New Indication
    September 10, 2014 – Medivation, Inc. and Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration approved a new indication for the use of Xtandi® (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC). Read More>


    New Drug Formulations

    Iluvien® (fluocinolone acetonide) Intravitreal Implant – New Formulation
    September 26, 2014 – Alimera Sciences, Inc., announced the approval by the U.S. Food and Drug Administration of Iluvien® for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Iluvien® was approved without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery. Read More> 

    Vitekta (elvitegravir) – New Formulation
    September 24, 2014 – The U.S. Food and Drug Administration approved Gilead Sciences’ integrase strand transfer inhibitor Vitekta(elvitegravir) for treatment-experienced HIV-positive adults. The drug is indicated for combination use with a protease inhibitor co-administered with Norvir® (ritonavir) plus one or more antiretrovirals (ARVs). It should be taken with food. Read More>

    Tybost® (cobicistat) – New Formulation
    September 24, 2014 – The U.S. Food and Drug Administration approved Gilead Sciences’ Tybost® (cobicistat) as a boosting agent to raise the drug levels of Reyataz® (atazanavir) or Prezista® (darunavir) in combination with other antiretrovirals (ARVs) to treat HIV. The drug is the second boosting agent to hit the market, after the widely used Norvir® (ritonavir). Read More>

    Contrave (bupropion/naltrexone) – New Formulation
    September 10, 2014 – The U.S. Food and Drug Administration approved Contrave® (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia). Read More>


    New Drug Shortage

    September 23, 2014

    September 22, 2014

    September 18, 2014


    New Drug Recall

    Potassium Chloride Injection (Baxter) – Drug Recall
    September 16, 2014 – Baxter International Inc. announced today it is voluntarily recalling one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 to the hospital/pharmacy/nurse level. The recall is due to shipping carton mislabeling. Read More>


    New Drug Safety

    Xolair® (omalizumab) – Drug Safety Communication
    September 26, 2014 – An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair® than in those who were not treated with Xolair®. As a result, FDA has added information about these potential risks to the drug label. Read More>

    New FDA Label Bolsters Safety Case for Chantix®
    September 24, 2014 – New government-approved labeling on Pfizer’s drug Chantix® suggests that the anti-smoking medication may not carry the risks of suicidal behavior that first earned it the Food and Drug Administration’s strongest warning more than five years ago. The FDA updated the drug’s label Monday September 22, 2014 to include data from a number of recent studies that found little to no evidence of psychiatric problems or suicidal tendencies in patients taking the twice-a-day tablet. Read More>


    Clinical and Pharmacy News

    Live MTM Outperforms Chart Review on Reducing Cholesterol
    September 29, 2014 – Among patients with cardiovascular disease (CVD), live medication therapy management (MTM) reduces low-density-lipoprotein (LDL) cholesterol significantly more than standard, chart-review MTM, according to a study published in the September-October 2014 issue of the Journal of the American Pharmacists Association. Read More>

    Pharmacy Shopping for ADHD Medications Similar to Opioids
    September 28, 2014 – Medications for attention-deficit hyperactivity disorder (ADHD) are prone to the same abuse, misuse, and diversion as opioids, research published in Drugs in R&D suggests. Using a pharmacy database encompassing 65% of US retail dispensing across all types of pharmacies, researchers from Janssen Research & Development, LLC, studied nearly 4.5 million ADHD patients who were dispensed ADHD medications between February 1, 2011, and January 31, 2012, and just over 6 million asthma patients who were dispensed asthma medications in that same time period. Read More>

    At White House, Prescription Drug Protesters Call for New FDA Chief
    September 28, 2014 – Hundreds gathered outside the White House to demand tighter regulation of prescription painkillers and the removal of Food and Drug Administration Commissioner Dr. Margaret Hamburg. Read More>

    CVS’ Caremark unit settles U.S. false claims allegations
    September 26, 2014 – Caremark LLC, a unit of CVS Health Corp, will pay $6 million to settle U.S. allegations that it knowingly failed to reimburse Medicaid for prescription drug costs paid on behalf of patients who were also covered by private health plans it administered. Read More>

    New Clinical Guidelines Developed for NSTE-ACS
    September 25, 2014 – New guidelines for management of patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) have been developed and published online September 23 in Circulation. Read More>

    Testosterone replacement therapy comes under scrutiny; FDA advisory panel rejects new drug
    September 19, 2014 – Concerned about the increased risk of heart attack or stroke, an advisory committee for the Food and Drug Administration on Wednesday recommended that drugs designed to boost levels of testosterone in the body should be used only by men with specific medical conditions affecting the testicles (such as a tumor, genetic condition or side effects caused by chemotherapy), and not for those who are simply being treated for the “Low T” condition. Read More>

    Combo COPD Therapy Best for Older Adults
    September 17, 2014 – A combination drug therapy of long-acting beta agonists and inhaled corticosteroids appears to be the best treatment for older adults with chronic obstructive pulmonary disease (COPD), especially those with asthma, according to a study published in the September 17 issue of the Journal of the American Medical Association. Read More>

    FDA Publishes New Purple Book for Biosimilars

    September 10, 2014 – The US Food and Drug Administration (FDA) announced that it has published a new book for biologics and biosimilars. The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products licensed by FDA under the Public Health Service Act (the PHS Act). The “Purple Book” is available here.


    340B News

    Apexus Wins HRSA Contract to Remain Prime Vendor of 340B Program
    September 29, 2014 – Apexus, LLC, the prime vendor for the 340B Drug Pricing Program, has announced that it has been selected by the Health Resources and Services Administration (HRSA) to continue serving in its role as the prime vendor through September 29, 2019. Read More>

    Hospitals in Tennessee, Nationally Making Millions off 340B Federal Program Meant to Help Needy
    September 24, 2014 – Hospitals and clinics across Tennessee and the United States are reportedly using a federal entitlement to pad their profits and subsidize other operations, depriving pharmaceutical manufacturers of revenue and jeopardizing future drug innovation. Read More>

    Drug prices soar as Big Pharma targets discount program
    September 16, 2014 – Until May 1999, the daytime speed limit in Montana was “reasonable and prudent.” Leadfoots from around the country called it the home of the Montanabahn. That’s very much how prices are set by the big drug companies today — with similar results. Last year, commonly used generic medicines spiked higher. Meanwhile, the pharmaceutical industry is trying to derail a vital federal drug discount program called 340B that helps hospitals and community health centers in Minnesota and across the country supply lower-cost medicines and enhanced services to underserved patients. Read More>

    340B Federal Drug Pricing Program September Update: Self-Disclosures
    September 15, 2014 – As part of its ongoing series of monthly 340B Federal Drug Pricing Program (340B Program) integrity updates, the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) released an update on September 8, 2014, covering self-disclosures (September Update). Read More>