Javelin Pharmaceuticals Inc (JAV)

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Javelin Pharmaceuticals Inc.' Receives FDA PDUFA Date For Dyloject NDA
Wednesday, 17 Feb 2010 08:55am EST
Javelin Pharmaceuticals Inc. announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject (diclofenac sodium) Injection, has received an FDA PDUFA date of October 3, 2010. This NDA review is in support of US marketing approval and registration of Dyloject for the management of acute moderate-to-severe pain in adults. If approved, Dyloject will be the first IV non-steroidal anti-inflammatory drug (NSAID) marketed in the United States as a single agent for the management of acute moderate-to-severe pain in adults since ketorolac in 1990. Javelin`s NDA includes 16 clinical studies evaluating over 2000 subjects dosed with Dyloject. It includes over 1300 US patients in two multi-dose, multiple-day placebo-controlled Phase 3 pivotal efficacy studies and one multi-dose, multiple-day open label safety study.

http://www.reuters.com/finance/stocks/keyDevelopments?rpc=66&symbol=JAV×tamp=20100412132500