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Regulatory and Washington

  • Blog: Sanofi sues FDA to delay publication of OTC Nasacort labeling

    WASHINGTON — Sanofi-Aventis has sued the Food and Drug Administration to keep its labeling for OTC Nasacort confidential in an effort to delay store brand competition until after the launch, according to an entry in the FDA Law Blog, the official blog of Hyman, Phelps & McNamara, published Thursday. 

  • FDA approves generic versions of Aciphex

    SILVER SPRING, Md. — The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.

    The FDA announced the approval of the first generic versions of Eisai's Aciphex (rabeprazole sodium) delayed-release tablets for patients aged 12 and older. The generic products are made by Dr. Reddy's Labs, Kremers Urban Pharmaceuticals, Lupin Pharmaceuticals, Mylan Pharmaceuticals, Teva Pharmaceuticals USA and Torrent Pharmaceuticals.

  • National Pharmaceutical Council elects Boehringer Ingelheim executive as chairman

    WASHINGTON — Boehringer Ingelheim SVP managed markets Jeff Huth has been elected by the National Pharmaceutical Council as chairman of the board for 2013-2014, the organization said Friday.

    Huth has served as a member of the NPC's board since 2009 and has previously had the positions of vice chairman and treasurer. The NPC, founded in 1953, describes itself as a health policy research organization focused on the advancement of science and medical innovation.

  • FDA rule would allow faster product safety information updates for generics

    SILVER SPRING, Md. — When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

  • NRF sees positive job growth in retail for October

    WASHINGTON — The retail industry added 37,600 jobs in October, and 295,000 year-over-year, according to a new report by a retail industry trade group.

    Analysing numbers from the Bureau of Labor Statistics, the National Retail Federation said the increase represented 2.4% boost over 2012, and every sector of retail added jobs except clothing retailers, which lost 12,500 jobs. Overall, according to the BLS, the economy added 204,000 jobs in October, and the unemployment rate was 7.3%.

  • FDA approves Sunovion's Aptiom as add-on therapy for epilepsy

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating epileptic seizures, the agency said Friday.

    The FDA announced the approval of Aptiom (eslicarbazepine acetate), made by Sunovion Pharmaceuticals, as an add-on medication for seizures in adults. About 200,000 new cases of seizures and epilepsy occur in the United States each year, according to the FDA.

  • International Diabetes Federation appoints Petra Wilson as CEO

    BRUSSELS — A former executive from Cisco has been appointed as CEO of the International Diabetes Federation.

    The IDF announced Thursday the appointment of Petra Wilson, who formerly served as Cisco's senior director of the European health and care business solutions team, working with the World Health Organization, the European Commission, governments and others.

  • FDA may ban trans fats from most foods

    SILVER SPRING, Md. — U.S. regulators made a preliminary move Thursday to remove trans fats from food products.

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