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Regulatory and Washington

  • FDA advisory committee recommends approval for schizophrenia, bipolar disorder drug

    MOUNTAIN VIEW, Calif. — A Food and Drug Administration panel has voted to recommend approval for a psychiatric drug made by Alexza Pharmaceuticals.

  • Tar Heel State to renew PSE Rx-only debate in two years

    RALEIGH, N.C. — North Carolina may be two years away from joining Oregon and Mississippi as the only states to classify pseudoepehdrine as a prescription-only medicine.

  • FTC approves Valeant's acquisitions of Dermik, Ortho Dermatologics

    MISSISSAUGA, Ontario — The Federal Trade Commission has voted to approve Valeant's acquisitions of Dermik, a unit of French drug maker Sanofi that makes drugs for skin conditions, and Ortho Dermatologics, a division of Johnson & Johnson that also makes skin drugs.

  • Report: New Wash. law cuts off patient access to painkillers

    NEW YORK — A new law in Washington state intended to curb accidental deaths related to opioid painkillers is having some adverse side effects, according to published reports.

  • Reports: N.Y. Gov. Cuomo signs controversial mail-order pharmacy bill

    NEW YORK — New York state Gov. Andrew Cuomo has signed into law a bill that would forbid health insurers from requiring plan members to order prescription drugs from mail-order pharmacies, according to published reports. 

  • HHS, Novartis celebrate opening of state-of-the-art, stateside vaccine facility

    WASHINGTON — The Department of Health and Human Services on Monday announced that the first U.S. facility to use a faster and more flexible technology to make influenza vaccine was dedicated as part of an initiative that could provide vaccine supplies sooner in an influenza pandemic.

  • FDA approves painkiller made by Sun Pharmaceutical Industries

    MUMBAI, India — The Food and Drug Administration has approved a generic painkiller made by Sun Pharmaceutical Industries, Sun said.

    Sun announced the approval of tramadol hydrochloride extended-release tablets, a generic version of Valeant International's Ultram ER. The drug is used to treat moderate to moderately severe chronic pain in adults who need constant treatment for an extended period of time.

    Various versions of the drug have annual sales of $125 million, according to Sun.

  • FDA approves crush-resistant painkiller by Endo

    CHADDS FORD, Pa. — The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.

    Endo announced the FDA's approval of a crush-resistant version of Opana ER (oxymorphone). Drug abusers often crush opioid pills in order to smoke, inhale or inject them. Endo developed the new formulation of the drug, scheduled for launch in 2012, using Grunenthal's Intac technology. The new version will otherwise be identical to the old one.

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