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Generics

  • 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.

  • PCMA leader: Generics, mail-order pharmacy help save money

    WASHINGTON — Mark Merritt, the president and CEO of the Pharmaceutical Care Management Association, responded to a provision on the Pentagon's new budget proposal, which encourages Tricare members to use generic medications and mail-service pharmacies to save money.

  • Mylan gets approval for generic version of Vfend

    PITTSBURGH — Mylan has launched a generic drug for fungal infections, the company said Tuesday.

    Mylan announced the launch, through subsidiary Mylan Pharmaceuticals, of voriconazole tablets in the 50-mg and 200-mg strengths. The drug is a triazole antifungal agent.

    The tablets are a generic version of Pfizer’s Vfend, which had sales of $186 million in 2010, according to IMS Health. Mylan launched its version of the drug under a settlement with Pfizer.

  • Watson's global generics business sees boost

    MORRISTOWN, N.J. — Watson's global generics business drove the drug maker's net revenue in the fourth quarter, according to a financial earnings release.

  • Report: Generic drug makers may look to diversify portfolios

    PHILADELPHIA — An increase in consolidation among generic drug companies could be in the works, according to a new report from Thomson Reuters.

    According to the report, “Gaining Market Share in the Generic Drug Industry Through Acquisitions and Partnerships,” generic drug makers face competition, as well as government-mandated price cuts in Europe and such policies as lowest-price tendering. As a result, many could seek deals that would cause them to diversify their portfolios.

  • E-prescribing of generics may be limited by pending legislation

    NEW YORK — Bills introduced in the legislatures of nearly a dozen states have pharmacy benefit managers and the generic drug industry fearing that the bills could lead to limits on doctors’ abilities to prescribe generics through e-prescribing.

    The Pharmaceutical Care Management Association, the main lobby for PBMs, said the bills would prohibit doctors from seeing lower-cost drug options, including generics and preferred brands; would prevent the e-prescribing software from showing safety information; and would disallow lower-cost pharmacy options.

  • FDA approves Quixin generic

    AMITYVILLE, N.Y. — The Food and Drug Administration has approved Hi-Tech Pharmacal’s generic version of a drug for eye infections.

    Hi-Tech announced the approval of levofloxacin ophthalmic solution in the 0.5% strength, a treatment for bacterial conjunctivitis. The company plans to launch next month.

    The drug is a generic version of Vistakon’s Quixin, which had sales of $2 million in 2010, according to IMS Health.

  • Mallinckrodt receives FDA approval for generic Duragesic

    ST. LOUIS — The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

    Mallinckrodt, part of Covidien, said the FDA approved its fentanyl transdermal system patch.

    The patch is a generic version of Johnson & Johnson’s Duragesic. The drug, an opioid and Class II controlled substance, is used for managing persistent, moderate-to-severe pain that requires continuous opioid administration.

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