FDA accepts Dyloject NDA

FDA accepted for filing an NDA from Javelin Pharmaceuticals Inc. (NYSE-A:JAV) for Dyloject diclofenac injection to manage acute moderate to severe pain. The company, which submitted the application on Dec. 2, said the agency has yet to issue a PDUFA date for the IV NSAID that inhibits cyclooxygenases (COX). Javelin made the submission under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. Myriad Pharmaceuticals Inc. (NASDAQ:MYRX) is acquiring Javelin (See BioCentury Extra, Friday, Dec. 18, 2009). ...