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Regulatory and Washington

  • CDC recommends Tdap for pregnant women

    ATLANTA — A panel at the Centers for Disease Control and Prevention recommends that pregnant women get vaccinated for whooping cough, the CDC said.

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • Watson, Actavis divest more drugs as condition for FTC merger approval

    NEW YORK – Watson Pharmaceuticals and Actavis will have to divest rights to almost two dozen drugs as a condition for U.S. regulatory approval of their $5.6 billion merger announced earlier this year, according to regulatory documents.

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