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Regulatory and Washington

  • Election analyst, professor Larry Sabato to address 2012 NACDS Annual Meeting

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores has announced that election analyst and University of Virginia professor Larry Sabato will address attendees at the 2012 NACDS Annual Meeting on April 21 to 24 in Palm Beach, Fla.

    Sabato will offer remarks to NACDS Annual Meeting attendees during the business program on Sunday, April 22. 

  • FDA approves Actavis ADHD drug

    MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic version of a drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Wednesday.

  • APhA releases pharmacy management guide

    WASHINGTON — The American Pharmacists Association has released a new information resource for pharmacists and pharmacy students about pharmacy management, the group said.

    The APhA announced Wednesday the release of "Getting Started as a Pharmacy Manager," a 171-page book for new and aspiring pharmacy managers about handling such managing issues as managing people, adhering to laws and regulations, and running a business.

  • FDA approves Prevnar 13 in older adults

    NEW YORK — The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said.

    Pfizer announced the FDA approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) as a single-dose for adults.

  • FDA panel to review potential new use for Xgeva

    THOUSAND OAKS, Calif. — Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.

  • FDA approves Mylan epilepsy drug

    PITTSBURGH — The Food and Drug Administration has approved a drug for epilepsy made by Mylan, the drug maker said.

    The FDA approved Mylan's levetiracetam extended-release tablets in the 500-mg and 750-mg strengths.

    The drug is a generic version of UCB's Keppra XR, used to treat partial onset seizures in epilepsy patients ages 16 years and older.

    Various versions of the drug had sales of about $162.8 million during the 12-month period ended in September, according to IMS Health.

  • FDA, CDC affirm safety of Mead Johnson's Enfamil; tests for Cronobacter negative

    GLENVIEW, Ill. — Mead Johnson's infant formulas, including Enfamil Premium Newborn, are safe, according to results of testing by both the Food and Drug Administration and the Centers for Disease Control and Prevention. These tests confirmed that the Mead Johnson products were safe, and no presence of the Cronobacter (Enterobacter sakazakii) bacteria was detected.

  • FDA accepts application for Gilead HIV drug

    FOSTER CITY, Calif. — The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

    Gilead said the FDA planned to review the application for the Quad by Aug. 27.

    The Quad combines four Gilead drugs — Truvada (emtricitabine and tenofovir disoproxil fumarate), cobicistat and elvitegravir — into one pill. The last drug was licensed from Japan Tobacco.

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