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Regulatory and Washington

  • FDA declines approval of United Therapeutics PAH drug

    SILVER SPRING, Md. — The Food and Drug Administration has declined to approve a drug developed by United Therapeutics Corp. for treating a potentially lethal high blood pressure condition.

    The drug maker said it received a complete response letter from the agency for its application for a tablet formulation of the drug treprostinil. The company already markets the drug in injectable and inhaled formulations for pulmonary arterial hypertension, or PAH, a condition that causes high blood pressure in the arteries of the lungs.

  • Catamaran gets $60 million in contracts from Indiana Medicaid program

    LISLE, Ill. — Pharmacy benefit manager Catamaran has won contracts with Indiana's state Medicaid program, the company said.

  • Ala. pharmacist appointed NCPA president for 2012-13

    ALEXANDRIA, Va. — The National Community Pharmacists Association has a new crop of leaders for 2012-13, the group said Wednesday.

    The new officers and board of directors, announced at the NCPA's 114th Annual Convention and Trade Exposition, are the group's governing body.

  • Mylan hopes to stop Watson launch of diabetes drug

    PITTSBURGH — Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

    The generic drug maker said it filed a motion in the U.S. District Court for the District of Columbia Tuesday to stay the court's order, which called on the FDA to let Watson launch a generic version of Takeda's Type 2 diabetes drug Actos (pioglitazone).

  • United Therapeutics awaits FDA decision on oral PAH drug as Sandoz seeks generic approval

    NEW YORK — The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

  • Federal court orders FDA to allow Watson diabetes drug launch

    PARSIPPANY, N.J. — A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

    Watson said the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson, ruling that the FDA would have to approve its generic version of Takeda's Actos (pioglitazone hydrochloride) tablets in the 15-mg, 30-mg and 45-mg strengths.

  • Sanofi Pasteur presents influenza vaccine trial data

    SWIFTWATER, Pa. — Sanofi Pasteur announced Monday the presentation of three clinical trials of an experimental influenza vaccine.

  • FDA approves Eisai's Fycompa for epilepsy

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for epilepsy, the agency said Monday.

    The FDA announced the approval of Eisai's Fycompa (perampanel) tablets to treat partial-onset seizures in patients ages 12 years and older. Partial seizures are the most common type seen in people with epilepsy, according to the FDA.

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