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Regulatory and Washington

  • FDA advisory committee recommends PrEP approval for Truvada

    FOSTER CITY, Calif. — An expert panel at the Food and Drug Administration has recommended that the agency approve a drug made by Gilead Sciences for lowering the risk of infection by the virus that causes AIDS.

  • NACDS applauds enactment of Alabama PBM audit legislation

    ALEXANDRIA, Va. — A law that will establish standards in the pharmacy audit process conducted by pharmacy benefit managers in the state of Alabama has received the applause of the National Association of Chain Drug Stores.

  • Watson seeks approval for generic ulcerative colitis drug

    PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is hoping to be the first to market a generic version of a drug used to treat ulcerative colitis, the company said.

    Watson announced that it had filed with the Food and Drug Administration through a subsidiary for melamine delayed-release tablets, a generic version of Shire Development's Lialda, in the 1.2-g strength. Watson's filing included a Paragraph IV certification, a legal assertion that Lialda's patent protection is invalid, unenforceable or won't be infringed.

  • FDA panel recommends approval for Pfizer RA drug

    NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Pfizer for treating rheumatoid arthritis.

  • Sandoz to testify at FDA biosimilars hearing

    HOLZKIRCHEN, Germany — The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

  • Reports: FDA may be close to approving drug for HIV prevention

    NEW YORK — The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.

    The Associated Press reported that the FDA had said Truvada (emtricitabine and tenofovir disoproxil fumarate), made by Gilead Sciences, appeared to be safe and effective for preventing HIV infection when taken daily. An FDA advisory committee will review the drug and decide whether to recommend its approval for pre-exposure prophylaxis, or PrEP.

  • NACDS urges congressional panel to preserve DME exemption for retail pharmacy

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced on Wednesday that it has submitted comments to the U.S. House Ways and Means Subcommittee on Health urging that retail pharmacies remain exempt from the Medicare durable medical equipment competitive bidding program. The subcommittee held a hearing regarding the program on Wednesday.

  • NCPA ends Legislative Conference with congressional rally

    ALEXANDRIA, Va. — The National Community Pharmacists Association wrapped up its three-day NCPA Legislative Conference Wednesday with a rally, the association announced.

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