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  • FDA panel declines to recommend new approval for J&J anticlotting drug

    RARITAN, N.J. — A Food and Drug Administration expert panel has recommended against expanding the approval of a Johnson & Johnson drug, the company said.

    J&J subsidiary Janssen Research & Development said the FDA's Cardiovascular and Renal Drugs Advisory Committee voted against recommending approval of Xarelto (rivaroxaban) combined with antiplatelet drugs to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome.

  • FDA approves treatment for vaginal fungus infections

    ALLEGAN, Mich. — The Food and Drug Administration has approved a generic treatment made by Perrigo for fungal infections of the vagina, the company said.

    Perrigo announced the approval of butoconazole nitrate 2% vaginal cream, a generic version of KV Pharmaceutical's Gynazole-1, used to treat vulvovaginal candidiasis, an infection caused by Candida fungus. KV voluntarily discontinued selling the drug in January 2009 due to manufacturing problems.

  • Pfizer names president, general manager of emerging markets, established business products

    NEW YORK — Pfizer has named one of its executives to a new position.

    Olivier Brandicourt — Pfizer's president and general manager of the primary care business unit and a member of the Pfizer executive leadership team — has been appointed president and general manager of the company's emerging markets and established business products business units, effective June 1. He succeeds David Simmons, who is leaving Pfizer to become the chairman and CEO of Pharmaceutical Product Development.

  • FDA approves Stiefel acne treatment

    NEW YORK — The Food and Drug Administration has approved a new treatment for acne made by a GlaxoSmithKline subsidiary.

    Stiefel announced the approval of Fabior (tazarotene) foam in the 0.1% strength, calling it the only retinoid in a topical foam for treating acne in patients ages 12 years and older.

    "Stiefel is dedicated to meeting th needs of patients and dermatologists, and we believe Fabior foam will be an important treatment option for people with moderate-to-severe acne," Stiefel VP North America dermatology Jean-Christophe May said.

  • Pfizer, EatingWell launch Lipitor For You mobile app

    NEW YORK — Pfizer has partnered with EatingWell magazine to launch the drug maker's Lipitor For You "Recipes 2 Go" mobile application.

  • COPD spurs drug development

    Taken together, asthma and chronic obstructive pulmonary disease — which includes chronic bronchitis and emphysema — affect nearly 50 million Americans, or about 15% of the total U.S. population, according to statistics from such organizations as the Centers for Disease Control and Prevention. And combined, the two diseases cause more than 100,000 deaths per year. Fortunately, however, there is a wide range of treatments available for both, many of which work for both diseases.

  • Study: Flu shots could provide unanticipated benefits to expectant moms

    OTTAWA — Getting a flu shot during pregnancy provides unanticipated benefits to the baby, according to the authors of a large population-based study examining the issue. Specifically, the study showed that H1N1 vaccination during the pandemic was associated with a significantly reduced risk of stillbirth, preterm birth and extremely small babies at birth.

  • Novo Nordisk's Levemir approved for children ages 2 to 5 years

    PRINCETON, N.J. — The Food and Drug Administration has approved a treatment for Type 1 diabetes in children ages 2 to 5 years.

    Drug maker Novo Nordisk announced Tuesday the additional approval of Levemir (insulin detemir [rDNA origin]). The insulin already was approved for Type 1 diabetes in older children and adults and Type 2 diabetes in adults, and the drug maker said the new FDA approval made Levemir the only basal insulin analog for use in the 2 to 5 year age group.

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