Generics

  • Sandoz first to receive FDA approval for Lovenox generic

    SILVER SPRING, Md. The Food and Drug Administration has approved the first generic version of a Sanofi-Aventis injected drug used to treat deep vein thrombosis, the agency said Friday.

     

    The FDA approved generic enoxaparin sodium, a version of Sanofi’s Lovenox, developed under a collaboration between Momenta Pharmaceuticals and Sandoz, the generics division of Swiss drug maker Novartis.

     

     

  • GPhA: Generic drug utilization can curb wasteful Medicaid spending

    WASHINGTON A reported excess of a quarter billion dollars is a good case for increasing use of generic drugs under the Medicaid program, according to the main lobby for the generic drug industry.

     

    Responding to a report by conservative think tank the American Enterprise Institute that identified $271 million in wasteful Medicaid spending, the Generic Pharmaceutical Association said it was a “compelling case” for increasing generic drug utilization.

     

     

  • Caraco launches generic Wellbutrin SR

    DETROIT Generic drug maker Caraco Pharmaceutical Labs has launched a generic antidepressant, Caraco said Wednesday.

     

    The drug maker announced the launch of bupropion hydrochloride extended-release tablets in the 150 mg and 200 mg strengths.

     

     

    The drug is a generic version of GlaxoSmithKline’s Wellbutrin SR. Various versions of the drug have annual sales of $300 million, according to Caraco.

     

  • FDA approves additional strengths of Actavis' generic Wellbutrin SR

    MORRISTOWN, N.J. Actavis has received regulatory approval from the Food and Drug Administration for a generic antidepressant, the drug maker announced Wednesday.

    Actavis said it immediately will begin distributing its bupropion HCl extended-release (SR) tablets in 100-mg and 200-mg strengths. The drug is the generic equivalent of GlaxoSmithKline's Wellbutrin SR. Actavis already has marketed generic Wellbutrin SR in the 150-mg strength. The drug maker received approval in March 2008.

  • Mylan gets green light for generic hypertension treatment

    PITTSBURGH Mylan subsidiary Mylan Technologies has received final approval from the Food and Drug Administration for its hypertension treatment, the generic drug maker said.

    Mylan said its clonidine transdermal system USP was approved in the 0.1 mg/day, 0.2 mg/day and 0.3 mg/day strengths. Mylan's CTS is the generic version of Boehringer Ingelheim's Catapres-TTS.

     

  • Teva launches generic Amerge

    NORTH WALES, Pa. Teva Pharmaceuticals has launched a drug for treating migraine headaches, the generic drug maker said.

     

    Teva announced the launch of naratriptan tablets in the 1 mg and 2.5-mg strengths. The tablets are a generic version of GlaxoSmithKline’s Amerge. The drug is used to treat acute migraine attacks in adults with or without visual disturbances preceding the attacks known as aura.

     

     

  • Mylan's generic arthritis drug receives FDA approval

    PITTSBURGH The Food and Drug Administration has approved a generic arthritis treatment made by Mylan, the drug maker said Wednesday.

     

    The FDA approved nabumetone tablets, a treatment for osteoarthritis and rheumatoid arthritis, in the 500 mg and 750-mg strengths.

     

     

  • Watson seeks FDA approval for generic Renvela, confirms patent challenge

    MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals hopes to be the first to market a version of a kidney disease treatment made by Genzyme, Watson said Monday.

    Watson said it filed a regulatory approval application with the Food and Drug Administration for sevelamer carbonate for oral suspension. The drug is a generic version of Genzyme’s Renvela, used to control serum phosphorus in patients with chronic kidney disease who are on dialysis.

     

  • Sandoz launches generic Amerge

    PRINCETON, N.J. Sandoz has launched a generic drug for treating migraine headaches, the generics arm of Swiss drug maker Novartis said Monday.

     

    Sandoz launched naratriptan hydrochloride tablets in the 2.5-mg strength, a generic version of GlaxoSmithKline’s Amerge. The tablets are used for treating acute migraine attacks in adults with or without visual disturbances that occur before the onset of the headache, also known as aura. Studies have indicated that around 12% of Americans have migraine attacks.

     

     

  • Roxane launches generic Amerge, Arimidex

    COLUMBUS, Ohio Roxane Labs announced Thursday the launch of two new generic drugs.

     

    The Columbus, Ohio-based generics subsidiary of German drug maker Boehringer Ingelheim, launched naratriptan tablets in the 1-mg and 2.5-mg strengths, and anastrozole tablets in the 1-mg strength.

     

     

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