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Generics

  • Impax confirms patent challenge for generic Detrol

    HAYWARD, Calif. — Pfizer has filed suit against generic drug maker Impax Labs in connection with the latter’s attempt to market a generic drug for bladder problems.

    Impax said Friday that Pfizer filed a patent infringement suit in the U.S. District Court of the District of New Jersey in connection with Impax’s attempt to market a generic version of Detrol (tolterodine tartrate) immediate-release tablets in the 1-mg and 2-mg strengths. The drug is used to treat overactive bladder and urinary incontinence.

  • Pfizer looks to block Watson from launching generic Viagra

    PARSIPPANY, N.J. — Generic drug maker Watson Labs is hoping to market a generic version of a Pfizer drug for erectile dysfunction.

    Watson announced Thursday that it had filed a regulatory approval application with the Food and Drug Administration to market a generic version of Viagra (sildenafil citrate) tablets in 25-mg, 50-mg and 100-mg strengths.

  • Teva's generic Aricept OKed by FDA

    JERUSALEM — The Food and Drug Administration has approved a generic drug for Alzheimer’s disease made by Teva Pharmaceutical Industries.

    The FDA approved Teva’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths.

    The drug is a generic version of Aricept, made by Pfizer and Eisai. Branded and generic versions of the drug had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.

  • Mylan gets go-ahead for generic Effexor XR

    PITTSBURGH — The Food and Drug Administration has approved a generic drug for depression and anxiety made by Mylan, the drug maker said Thursday.

    Mylan announced the approval of venlafaxine hydrochloride extended-release capsules in the 37.5-mg, 75-mg and 150-mg strengths.

    The drug, used to treat major depressive disorder and social anxiety disorder, is a generic version of Effexor XR, made by Wyeth. Mylan is launching the drug under a licensing agreement it made with Wyeth before its purchase by Pfizer.

  • Drug shortage bill enters Senate

    NEW YORK — Legislation recently introduced in the Senate aims to address the issue of drug shortages.

    The Preserving Access to Life-Saving Medications Act, introduced in February by Sen. Amy Klobuchar, D-Minn., would require drug manufacturers to inform the Food and Drug Administration when supplies of a drug may be running low, allowing the agency to inform hospitals and attempt to address shortages.

    The bill currently has nine cosponsors and is under review by the Senate Committee on Health, Education, Labor and Pensions, according to congressional records.

  • Sandoz gets green light for two generic Alzheimer's disease drugs

    PRINCETON, N.J. — Sandoz has launched generic versions of treatments for Alzheimer’s disease, the generic pharmaceuticals division of Swiss drug maker Novartis said Wednesday.

    Sandoz announced the launch of donepezil hydrochloride film-coated tablets and donepezil hydrochloride orally disintegrating tablets, which are generic versions of Eisai and Pfizer’s Aricept and Aricept ODT, respectively.

    Donepezil hydrochloride film-coated and orally disintegrating tablets had sales of $2.3 billion in the 12-month period ended in March, according to IMS Health.

  • Actavis' generic Aricept gets FDA nod

    MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for Alzheimer’s disease made by Actavis, the drug maker said Tuesday.

    The FDA approved the company’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths, a generic version of Eisai and Pfizer’s Aricept. Donepezil hydrochloride tablets in the two strengths had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.

  • Taro reports rise in Q1 sales

    HAWTHORNE, N.Y. — Taro realized a 21% increase in net sales for its first quarter, the drug maker said.

    The company said it raked in net sales of $107.7 million, an increase of $18.7 million. Diluted earnings per share totaled 58 cents, compared with 21 cents in the prior-year period.

    Operating income for Taro increased 84.4% to $33.4 million, or 31% of net sales, compared with $18.1 million, or 20.3% of net sales, in 2010.

    During the period, Taro received three abbreviated new drug applications from the Food and Drug Administration.

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