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Regulatory and Washington

  • Watson confirms Welchol patent challenge

    PARSIPPANY, N.J. — Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

    The drug maker said Wednesday that it had filed with the Food and Drug Administration for approval of a generic version of Welchol (colesevelam hydrochloride) tablets in the 625-mg strength, made by Daiichi Sankyo, thus challenging the patents covering the drug.

  • GSK, Valeant respond to CRL for ezogabine

    LONDON — GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

  • FDA warns companies to stop making MRSA claims for over-the-counter products

    SILVER SPRING, Md. — The Food and Drug Administration on Wednesday issued four warning letters to companies that manufacture and market over-the-counter drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria, or MRSA.

  • J&J: McNeil production to slow down

    NEW BRUNSWICK, N.J. — Johnson & Johnson on Tuesday announced that distribution of McNeil Consumer Healthcare consumer products will slow in the coming months as the company shifts production of its over-the-counter medicines to other manufacturing plants and implements additional third-party quality controls within those plants.

  • John Coster joins NCPA, heads up new advocacy center

    ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday named longtime industry veteran John Coster as SVP government affairs and head of the association’s newly created NCPA Advocacy Center.

    The NCPA Advocacy Center will unite the association’s government affairs, grassroots, pharmacy benefit manager transparency, professional affairs and public affairs programs to enhance NCPA advocacy efforts and ensure that they have the maximum impact possible.

  • Mylan launches generic Famvir

    PITTSBURGH — Mylan has launched a generic drug for treating herpes, the company said Wednesday.

    Mylan announced the launch of famciclovir tablets in the 125-mg, 250-mg and 500-mg strengths. The drug is a generic version of Novartis’ Famvir.

    Branded and generic versions of the drug had sales of $196 million in 2010, according to IMS Health.

  • NACDS expands state government affairs team

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced on Wednesday that Joel Kurzman has joined its state government affairs team as a director.

  • Rituxan OKed as treatment for two inflammatory diseases

    SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

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