Regulatory and Washington

  • Appeals court upholds decision to OK 'pay-for-delay' deals

    NEW YORK The federal government got a kick in the face Thursday as an appeals court ruled in favor of patent litigation settlements between branded and generic drug companies.

  • FDA approves expanded use of Saphris

    WHITEHOUSE STATION, N.J. Merck's supplemental drug applications for its atypical antipsychotic received approval from the Food and Drug Administration, the drug maker said.

    Saphris now is indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, Merck said.

  • Perrigo gets approval for generic Aldara

    ALLEGAN, Mich. The Food and Drug Administration has approved Perrigo's generic drug for treating skin diseases, the drug maker said Wednesday.

     

    The FDA approved Perrigo’s imiquimod cream in the 5% strength. The drug is a generic version of Graceway Pharmaceuticals’ Aldara.

     

     

    The drug is used to treat actinic keratoses on the face and scalp, superficial basal cell carcinoma and external genital and perianal warts in patients ages 12 years and older.

     

  • Watson gets FDA approval for generic Yasmin

    MORRISTOWN, N.J. The Food and Drug Administration has approved a generic oral contraceptive made by Watson Pharmaceuticals, the drug maker said Tuesday.

     

    Watson announced the FDA’s approval of Zarah (drospirenone and ethinyl estradiol tablets) in the 3 mg/0.03 mg strength. The drug is a generic version of Bayer’s Yasmin.

     

     

  • CMS chief Berwick is driving hard to spur health innovation, report says

    WASHINGTON The recently installed head of the federal Medicare program is pushing hard to promote new and more cost-effective ways to treat patients and improve the nation’s health scorecard.

  • NACDS, NCPA in joint statement praise CMS' move to withdraw provisions of AMP rule currently blocked by injunction

    ALEXANDRIA, Va. National Association of Chain Drug Stores president and CEO Steve Anderson and National Community Pharmacists Association acting EVP and CEO Douglas Hoey issued a statement praising the proposed rule by the Centers for Medicare and Medicaid Services that would withdraw existing provisions of the Medicaid pharmacy reimbursement formula under the average manufacturer price model.

  • Actavis' generic Strattera gets OK from FDA

    MORRISTOWN, N.J. The Food and Drug Administration has approved a generic drug made by Actavis for treating attention deficit hyperactivity disorder, Actavis said Wednesday.

     

    The FDA approved the drug maker’s atomoxetine hydrochloride capsules in the 10-mg, 18-mg, 25-mg, 40-mg, 60-mg, 80-mg and 100-mg strengths. The drug is a generic version of Eli Lilly’s Strattera, which had $532 million in sales during the 12-month period ended in June, according to IMS Health.

     

     

  • Allergan's elevated intraocular pressure treatment gets nod from FDA

    IRVINE, Calif. Allergan's optimized reformulation of Lumigan has received approval from the Food and Drug Administration, the drug maker said Wednesday.

    Lumigan 0.01% (bimatoprost ophthalmic solution) is a first-line therapy indicated for the reduction of elevated intraocular pressure with open-angle glaucoma or ocular hypertension, Allergan said. Lumigan 0.01% will be available in fourth quarter 2010 as the newest addition to Allergan’s comprehensive glaucoma portfolio.

     

  • FDA approves Sun's generic Strattera

    MUMBAI, India A generic drug maker has received regulatory approval for its version of an attention deficit hyperactivity disorder treatment.

    Sun Pharmaceutical Industries' subsidiary has received approval to market its generic version of Strattera (atomoxetine hydrochloride capsules), an ADHD drug for children ages 6 years and older, as well as teens and adults. Strattera is made and marketed by Eli Lilly.

    Annual sales of branded and generic atomoxetine hydrochloride capsules are estimated to be more than $530 million.

  • Salmonella not a threat to flu vaccine production

    NEW YORK Despite concerns that this year's flu vaccine production will be affected by the recent salmonella outbreak, a Food and Drug Administration official and a drug maker advised that is not the case, according to published reports.

    Although chicken eggs, which were said to be the source of this summer's salmonella outbreak, are used to make the flu vaccine, an FDA spokeswoman said that chicken eggs used in creating the flu vaccine are fertilized, unlike those used for consumption.

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