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  • Genzyme's board recommends shareholders OK Sanofi offer

    CAMBRIDGE, Mass. — The board of directors of Genzyme unanimously recommended that shareholders accept French drug maker Sanofi-Aventis’ $74-per-share buyout offer, Genzyme said Monday.

    Genzyme recently accepted Sanofi’s $20.1 billion offer for the Cambridge, Mass.-based biotech company. Sanofi had sought to buy the company since last July, when it offered $18.5 billion, or $69 per share.

  • FDA lifts liver injury risk boxed warning from Gilead's Letairis

    FOSTER CITY, Calif. — Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker's hypertension treatment.

    Gilead said the FDA approved a change to the prescribing information for Letairis (ambrisentan 5-mg and 10-mg tablets), the company’s once-daily treatment of pulmonary arterial hypertension.

  • Eisai's Banzel OKed as epilepsy treatment

    WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.

    The FDA approved Banzel (rufinamide) oral suspension for the treatment of seizures in children and adults with Lennox-Gastaut syndrome. The condition, also called LGS, affects 1% to 4% of children with epilepsy.

    “This new formulation provides an option for patients who may prefer a liquid or find it difficult to take the medication in tablet form,” Eisai president and CEO Lonnel Coats said.

  • ReportersNotebook — Chain Pharmacy, 3/14/11

    SUPPLIER NEWS — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment. The drug maker said the FDA approved its 150-mg doxycycline monohydrate capsules, a drug used to treat bacterial infections and a generic version of Adoxa, made by Nycomed subsidiary PharmaDerm. The 150-mg strength of Adoxa had sales of about $25 million during the 12 months ended in December 2010, according to Wolters Kluwer.

  • Endo elects new board member

    CHADDS FORD, Pa. — Endo's board of directors has expanded to nine members with the addition of David Nash.

    Nash, who is the founding dean of the Jefferson School of Population Health at Thomas Jefferson University in Philadelphia, also serves as a board member for Humana.

    Endo chairman, Roger Kimmel, said the board welcomes Nash's contributions as Endo continues to diversify its business.

  • FDA: Topiramate could pose birth defects risk

    SILVER SPRING, Md. — Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

    The FDA said Friday that the drug topiramate could increase the risk for such birth defects as cleft palate and cleft lip when used by expectant mothers. Johnson & Johnson markets the drug under the name Topamax, and it is available in generic form.

  • NSAIDs could pose erectile dysfunction risk among men

    PASADENA, Calif. — Long-term use of a class of drugs used to control pain could increase the risk of erectile dysfunction in men, according to a new study.

    The study, sponsored by Kaiser Permanente and published online in the Journal of Urology, found that men who took nonsteroidal anti-inflammatory drugs, or NSAIDs, three times a day for more than three months were 2.4 times as likely to have erectile dysfunction as men who didn’t take the drugs regularly. The study used data from 80,966 men ages 45 to 69 years in California.

  • Endo launches Fortesta

    CHADDS FORD, Pa. — Endo Pharmaceuticals has launched a recently approved testosterone gel for men.

    Endo announced Thursday the launch of Fortesta, approved by the Food and Drug Administration for treating low testosterone — or low T — in men, which affects about 14 million men in the United States; around 1.3 million of those men currently are receiving treatment, according to Endo.

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