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Regulatory and Washington

  • FDA approves Lannett obesity drug

    PHILADELPHIA — The Food and Drug Administration has approved a generic drug for obesity made by Lannett, the drug maker said Tuesday.

    Lannett announced the approval of phentermine hydrochloride capsules in the 15-mg strength.

    Various versions of the drug had sales of $11 million at average wholesale price in 2011, according to Wolters Kluwer.

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  • FDA approves Vertex's Kalydeco for cystic fibrosis

    SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

    The FDA announced the approval of Kalydeco (ivacaftor) for treating patients ages 6 years and older with CF who have a mutation called G551D in the cystic fibrosis transmembrane regulator gene.

  • FDA approves Hi-Tech Pharmacal's anxiety drug

    AMITYVILLE, N.Y. — The Food and Drug Administration has approved a generic drug for anxiety made by Hi-Tech Pharmacal, the drug maker said Tuesday.

    The FDA approved Hi-Tech's lorazepam oral concentrate in the 2-mg-per-mL strength, a generic version of Roxanne Labs' Intensol.

    Branded and generic versions of the drug had sales of $10 million in 2011, according to IMS Health.

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  • J&J recalls one lot of Aveeno Baby Calming Comfort lotion

    NEW BRUNSWICK, N.J. — Johnson & Johnson Consumer Cos. last week voluntarily recalled from retailers one lot of Aveeno Baby Calming Comfort lotion that was distributed in Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Mississippi, Tennessee and Texas.

    This is not a consumer level recall and no action is required by consumers, the company stated.

  • NACDS Foundation names winners of pharmacy student scholarship awards

    ALEXANDRIA, Va. — The charitable arm of the National Association of Chain Drug Stores has announced the 2011 recipients of its pharmacy student scholarship awards.

    The NACDS Foundation said a total of 58 scholarships were awarded, representing 42 colleges and schools of pharmacy.

  • PDUFA reauthorization goals draw support from NACDS

    ALEXANDRIA, Va. — A goal to standardize risk evaluation and mitigation strategies and modernize the U.S. drug safety system in a proposed reauthorization of the Prescription Drug User Fee Act has drawn support from the country's main chain retail pharmacy lobby.

    The National Association of Chain Drug Stores submitted written testimony Tuesday ahead of a congressional hearing on the reauthorization of PDUFA, originally enacted in 1992.

  • NACDS, NCPA urge guidance for states on Medicaid reimbursements

    ALEXANDRIA, Va. — Two groups representing the retail pharmacy industry are urging the federal government to provide guidance to the states on how to adjust Medicaid dispensing fees to determine pharmacy reimbursement.

  • Several Congress leaders caution Tricare on proposed ESI-Medco merger

    ALEXANDRIA, Va. — Several Congress leaders last week penned a letter to the Department of Defense's Director of Tricare Management Activity warning of potential cost increases should the proposed merger between pharmacy benefit managers Express Scripts and Medco Health clear regulatory hurdles.

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