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Generics

  • Dr. Reddy's launches generic Alzheimer's disease drug

    HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug used to treat Alzheimer's disease, the company said.

    The Indian drug maker announced the launch of donepezil hydrochloride tablets in the 23-mg strength, a generic version of Eisai and Pfizer's Aricept. The drug is being launched in 30- and 90-count bottles.

    Aricept in the 23-mg strength had sales of about $92.6 million during the 12-month period that ended in May, according to IMS Health.

     

  • Anda VP purchasing Marc Falkin to join Actavis

    WESTON, Fla. — One of Anda's executives is moving to Actavis after 12 years at Anda.

    Anda VP purchasing Marc Falkin has announced that he is leaving the company, and will join Actavis as VP marketing, pricing and contract operations for the Parsippany, N.J.-based drug maker's generics business. Anda executive director of purchasing Anthony Mihelich will assume Falkin's responsibilities in the interim.

     

  • Senate to consider drug supply chain bill

    ALEXANDRIA, Va. — A new track-and-trace bill that the Senate is expected to consider would institute a nationwide "track-and-trace" system in place of patchwork state laws with the aim of securing the pharmaceutical supply chain.

    S. 959 also seeks to respond to last year's meningitis outbreak by establishing a list of "do not compound" medications.

  • Court strikes down eight of Teva's patents on Copaxone

    PRINCETON, N.J. — A federal court has ruled in favor of generic drug maker Sandoz in a case involving a drug for multiple sclerosis, Sandoz said.

    Sandoz, the generics division of Switerland-based Novartis, said the U.S. Federal Circuit Court of Appeals invalidated nine patents owned by Israel-based Teva Pharmaceutical Industries covering the drug Copaxone (glatiramer acetate).

  • Mylan can launch authorized generic Parkinson's drug under settlement

    PITTSBURGH — Mylan and Orion Corp. have settled a patent-infringement suit over a drug used to treat Parkinson's disease, Mylan said Thursday.

    The generic drug maker had filed with the Food and Drug Administration for a generic version of Orion's Stalevo (carpidopa; levodopa; entacapone) tablets, used to treat idiopathic Parkinson's to substitute for immediate-release carbidopa/levodopa and entacapone administered separately.

  • FDA grants exclusivity to Teva's Plan B contraceptive

    WASHINGTON — The Food and Drug Administration has granted the manufacturer of Plan B One-Step exclusive marketing rights for three years, according to published reports.

    According to the New York Times, the decision by the FDA sets Teva Pharmaceuticals as the only company able to sell the drug over-the-counter and without a prescription to a person of any age.

  • Lupin wins approval for generic diabetes drug

    MUMBAI, India — The Food and Drug Administration has approved a generic diabetes drug made by Lupin, the company said.

    Lupin, based in India, received approval for metformin hydrochloride extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Santarus' Glumetza.

    Glumetza had sales of about $144 million during the 12-month period that ended in March, according to IMS Health. The drug is an extended-release formulation of metformin hydrochloride, a widely prescribed drug used for treating Type 2 diabetes.

     

  • Court rules in favor of Mylan in suit against GSK over antidepressant drug

    PITTSBURGH — A federal court has ruled that a Mylan lawsuit against GlaxoSmithKline over an antidepressant drug can go to trial, Mylan said Tuesday.

    Mylan alleges that GlaxoSmithKline breached a contract the two companies had made when it agreed to supply competing drug maker Apotex with paroxetine hydrochloride extended-release tablets, a generic version of Paxil CR. The Third Circuit Court of Appeals' ruling reversed a summary judgment dismissing Mylan's claim.

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