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Regulatory and Washington

  • FDA advisory committee recommends approval for Astellas overactive bladder drug

    DEERFIELD, Ill. — A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.

    The drug maker announced that the FDA Reproductive Health Drugs Advisory Committee voted 7-4 with one abstention that its assessment of the risks and benefits of the drug YM178 (mirabegron) supported the drug's approval.

    The FDA is not required to follow the recommendations of advisory committees, but usually does. The agency is expected to decide whether or not to approve the drug by June 29.

  • Par launches generic version of Provigil

    WOODCLIFF LAKE, N.J. — Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.

    Par announced the launch of a generic version of Provigil (modafinil), used to treat such sleep disorders as narcolepsy and work shift sleep disorder.

  • Teva entitled to exclusivity on Provigil, FDA decides

    JERUSALEM — Teva is the first company to file for a generic version of a drug used to treat sleep disorders, the Food and Drug Administration has determined, though Mylan is contesting the FDA decision.

  • FDA advisory committee to review OTC availability of HIV test in May

    BETHLEHEM, Pa. — OraSure Technologies on Wednesday announced that the Food and Drug Administration's Blood Products Advisory Committee will consider making its OraQuick Rapid HIV-1/2 test available over the counter on May 15.

    At the meeting, OraSure will present its consumer-usage studies — approximately 5,800 subjects were enrolled and tested in this phase across 20 states, the company said, which helped identify more than 100 previously undiagnosed individuals.

  • FDA approves UCB drug for Parkinson's, restless legs syndrome

    ATLANTA — The Food and Drug Administration has approved a patch for treating restless legs syndrome and Parkinson's disease.

    UCB announced the FDA approval of Neupro (rotigotine) transdermal system advanced-stage idiopathic Parkinson's and moderate-to-severe restless legs syndrome.

  • NACDS submits comments to CMS regarding Medicaid pharmacy reimbursement provisions of healthcare-reform law

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores has submitted official comments to the Centers for Medicare and Medicaid Services regarding its proposed rule on Medicaid pharmacy reimbursement using the average manufacturer price model. The AMP model was reformed by the Patient Protection and Affordable Care Act.

  • Patents covering Sanctura XR invalid, court rules

    PARSIPPANY, N.J. — A court has ruled that patents covering a drug designed to treat an overactive bladder are invalid, a company looking to launch a generic version of the drug said.

    Watson Pharmaceuticals said the U.S. District Court for the District of Delaware ruled that five patents covering Allergan's Sanctura XR (trospium chloride) extended-release capsules were invalid. Watson's application with the Food and Drug Administration for a generic version are pending, the company said.

  • Amylin seeks FDA approval for metreleptin

    SAN DIEGO — Drug maker Amylin Pharmaceuticals has filed for regulatory approval of a drug to treat diabetes and elevated triglycerides in the bloodstream in children and adults with a rare disorder.

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