International Business News - FDA http://www.ibtimes.com All articles are copyrighted by IBTimes.com 400 100 http://www.ibtimes.com/ http://www.ibtimes.com/images/top_logo_ibt2_3.gif Pozen Inc said U.S. health regulators have accepted a marketing application for its experimental pain drug Vimovo, triggering a $10 million milestone payment from AstraZeneca to Pozen. http://www.ibtimes.com/articles/20090831/update-pozen-says-us-fda-accepts-vimovo-marketing-application.htm Mon, 31 Aug 2009 10:43:53 EDT WASHINGTON - U.S. drug reviewers questioned findings from biotech company Allos Therapeutics Inc (ALTH.O) on the effectiveness of its proposed drug for an aggressive type of lymphoma, documents released on Friday showed. http://www.ibtimes.com/articles/20090828/update-us-fda-staff-question-allos-lymphoma-drug-data.htm Fri, 28 Aug 2009 13:10:26 EDT Aug 28 - Specialty pharmaceutical company Eurand NV (EURX.O) said U.S. health regulators approved its pancreatic enzyme product, Zenpep, to treat the inability to digest food due to a lack of enzymes made by the pancreas http://www.ibtimes.com/articles/20090828/eurand-gets-fda-nod-pancreatic-enzyme-product.htm Fri, 28 Aug 2009 09:19:06 EDT WASHINGTON - U.S. drug reviewers questioned a Genzyme Corp (GENZ.O) study meant to back wider use of the company's Clolar leukemia drug, according to documents released on Friday ahead of an advisory panel review. http://www.ibtimes.com/articles/20090828/us-fda-staff-question-genzyme-leukemia-drug-study.htm Fri, 28 Aug 2009 08:28:22 EDT The Food and Drug Administration issued a final rule Tuesday that requires manufactures of over-the-counter (OTC) products to revise their labeling including warnings about potential safety risks, such as internal bleeding and liver damage to help the consumers use products safely. http://www.ibtimes.com/articles/20090428/fda-requires-labeling-otc-pain-relievers-and-fever-reducers.htm Tue, 28 Apr 2009 20:12:32 EDT