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  • Covis acquires U.S. rights to five GSK drugs

    ZUG, Switzerland — A Swiss drug maker is acquiring the U.S. rights for several GlaxoSmithKline drugs.

    Covis Pharma Sarl announced Thursday that it had acquired the rights to the antibiotic Fortaz (ceftazidime), the antibiotic Zinacef (cefuroxime), the heart arrhythmia drug Lanoxin (digoxin), the antidepressant Parnate (tranylcypromine sulfate) and the gastroesophogeal reflux disease drug Zantac (ranitidine hydrochloride). GSK will retain rights to the drugs outside the United States.

    Financial terms of the deal were not disclosed.

  • Pfizer announces Embeda post-market trial results

    NEW YORK — A Pfizer painkiller appears to produce a much less positive experience for recreational drug users when crushed than when administered whole, according to results of a post-market clinical study program.

  • Valeant completes iNova acquisition

    MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals officially owns an Australian drug maker.

    The company announced that it completed its acquisition of iNova, which sells and distributes prescription and over-the-counter drugs in Australia, New Zealand, Southeast Asia and South Africa, on Dec. 21 from iNova's current shareholders, Archer Capital, Ironbridge and others.

    The deal, which was announced back in November, was valued at up to A$700 million.

  • Merck's Isentress approved for children, adolescents

    SILVER SPRING, Md. — The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

    The FDA announced the approval of Merck's Isentress (raltegravir) for HIV-1 infection in patients ages 2 to 18 years. The chewable form of the drug will be available for children ages 2 to 11 years.

    "Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," FDA Office of Antimicrobial Products director Edward Cox said.

     

  • Santarus applies for approval of ulcerative colitis drug

    SAN DIEGO — Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

    The application was for Uceris (budesonide) tablets in the 9-mg strength for moderate active UC. The company is developing the drug under a collaboration with Cosmo Technologies.

     


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  • FDA approves Takeda's Edarbyclor

    DEERFIELD, Ill. — The Food and Drug Administration has approved a new drug for high blood pressure made by Takeda, the drug maker said.

    The Japanese drug maker received approval for Edarbyclor (azilsartan medoxomil and chlorthalidone) for the treatment of high blood pressure, also known as hypertension. The company called it the only fixed-dose therapy that combines an angiotensin II receptor blocker with chlorthalidone, a diuretic, in a once-daily, single tablet. The company also markets Edarbi, which only contains azilsartan medoxomil.

  • Impax seeks approval for Parkinson's disease treatment

    HAYWARD, Calif. — The branded subsidiary of Impax Labs has submitted a new drug application for its investigational idiopathic Parkinson's disease treatment to the Food and Drug Administration.

  • Pfizer submits regulatory application for rheumatoid arthritis drug to FDA

    NEW YORK — Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

    The company said the FDA accepted a new drug application for tofacitinib for review. The agency also has provided an anticipated Prescription Drug User Fee Act action date of August 2012. Tofacitinib, which is a novel, oral JAK inhibitor, currently is under review by the European Medicines Agency.

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