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Generics

  • GPhA announces executive committee, board of directors

    ORLANDO, Fla. — The Generic Pharmaceutical Association has elected its 2011 executive committee and board of directors, the generic drug industry trade group announced. As part of a reorganization last year, the board has been reduced to 12 members.

    The GPhA said Watson Pharmaceuticals president and CEO Paul Bisaro had been reelected as chairman for a second, one-year term. Also elected were Mylan Pharmaceuticals president Tony Mauro, as vice chairman; and Momenta Pharmaceuticals president Craig Wheeler, as secretary treasurer.

  • Perrigo files regulatory application for Taclonex generic

    ALLEGAN, Mich. — Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

    Perrigo announced Tuesday that it had filed an application with the FDA for calcipotriene and betamethasone dipropionate in the 0.005%/0.064% strength. The drug is a generic version of Leo Pharma’s Taclonex and is used to treat psoriasis vulgaris in adults.

  • Impax granted FDA approval for generic Adoxa

    HAYWARD, Calif. — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

    The drug maker on Friday said it received final approval of its abbreviated new drug application for doxycyline monohydrate capsules in the 150-mg strength. The drug, which is a tetracycline antibiotic used to treat bacterial infections, is a generic version of Adoxa. Adoxa is manufactured by PharmDerm, a Nycomed subsidiary.

    Impax said its generic division, Global Pharmaceuticals, will launch the product.

  • As innovaters prep for patent cliff, generics prosper from patent losses

    A whole slew of drugs will lose patent protection this year, opening up opportunities for generic drug makers to market their own versions. Most notable among these is Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin), the world’s top-selling drug, with U.S. sales of $7 billion during the 12 months ended September 2010, according to IMS Health.


  • Industry advocates tout increase in generics use

    Generic drug usage already has been on the rise year after year, with no sign of slowing down. As Jody Fisher, VP marketing for healthcare analytics at market research firm SDI, has told Drug Store News, generics accounted for more than 70% of products dispensed at retail pharmacies and are set to increase further this year.


  • ReportersNotebook — Chain Pharmacy, 2/28/11

    SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



  • Anticipating regulations, biosimilars move through pipeline

    Though efforts to repeal the Patient Protection and Affordable Care Act via the court system remain under way — with recent victories for opponents in Virginia and Florida — the attempt to repeal the healthcare-reform bill in Congress failed, thus leaving the bill and, most importantly, the regulatory approval pathway for follow-on biologics intact.


  • Report: Exclusivity period for biotech drugs may be reduced to seven years

    WASHINGTON — The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

    According to the reports, the administration would lower the 12-year data exclusivity period for biotech drugs mandated in the healthcare-reform law to seven years.

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