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Generics

  • Watson confirms patent challenge for generic Azilect

    MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals is seeking approval for a generic treatment for Parkinson’s disease, prompting a lawsuit from the drug’s manufacturer.

     

    Watson said Tuesday that Watson Labs, a subsidiary of the company, had filed for approval for rasagiline mesylate tablets, a treatment for Parkinson’s used either alone or with the drug levodopa. The drug is a generic version of Teva Neuroscience’s Azilect.

     

     

  • FDA approves Par and Tris Pharma's generic Tussionex

    WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved a generic treatment for cough and upper respiratory symptoms resulting from colds and allergies made by Par Pharmaceutical and Tris Pharma, Par said Tuesday.

    The FDA approved hydrocodone polistirex and chlorpheniramine polistirex extended-release oral suspension. The drug is a generic version of UCB’s Tussionex, which has annual sales of around $226 million, according to IMS Health.

     

  • Report: Ranbaxy to market generic Aricept

    NEW YORK Ranbaxy has won the right to sell a generic version of an Alzheimer’s disease drug made by Eisai, according to published reports.

    Bloomberg reported Tuesday that the Indian drug maker had won 180 days’ exclusivity in which to market a generic version of Eisai’s Aricept (donepezil hydrochloride) tablets, pending final Food and Drug Administration approval, beating out Israel-based Teva Pharmaceutical Industries.

  • Mylan subsidiary gets approval for HIV generic under PEPFAR

    PITTSBURGH The Food and Drug Administration has approved a generic drug for HIV made by a subsidiary of Mylan under a program that supplies drugs to people living with HIV in developing countries, Mylan said Tuesday.

     

  • Mylan's generic leukemia drug gets green light from FDA

    PITTSBURGH The Food and Drug Administration has approved a generic chemotherapy drug made by Mylan.

     

    The Pittsburgh-based drug maker said Monday that it had received approval for the injected drug fludarabine phosphate in the 25-mg-per-mL strength. The FDA determined the drug to be therapeutically equivalent to Teva Parenteral’s fludarabine phosphate.

     

     

  • Mylan's generic Wellbutrin XL enters market

    PITTSBURGH Mylan has launched a generic version of a common antidepressant, the company said Friday.

     

    Mylan announced the launch of bupropion hydrochloride extended-release tablets in the 150-mg and 300-mg strengths, a once-daily treatment for depression.

     

     

    The drug is a generic version of GlaxoSmithKline’s Wellbutrin XL. Various versions of the drug had sales of around $752 million during the 12-month period ended in June, according to IMS Health.

     

  • Sun Pharma gets FDA approval for ALS generic

    MUMBAI, India The Food and Drug Administration has approved a generic version of a drug for a devastating muscular disorder.

     

    Sun Pharmaceutical Industries announced Tuesday the approval of riluzole hydrochloride in the 50-mg strength. The tablets are used to treat amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease.

     

     

    The drug is a generic version of Sanofi-Aventis’ Rilutek, which has sales of around $50 million, according to Sun.

     

  • Decision Resources: Generic competition will crush hypertension drug market

    BURLINGTON, Mass. The market for hypertension drugs will drop by $3 billion by the end of the decade due to generic competition, according to a new report by healthcare market research firm Decision Resources.

    The report, announced Tuesday, found that the market for drugs to treat high blood pressure would decline from 2009’s $26 billion to $23 billion by 2019 in the United States, United Kingdom, France, Italy, Spain and Japan.

     

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