Javelin Pharmaceuticals Inc (JAV)

[surf1944]

8:55AM Javelin Pharmaceutic says FDA accepts its Dyloject New Drug Application for formal review (JAV) 1.19 : Co announces that its New Drug Application submitted on December 2, 2009 to the FDA for its investigational product candidate, Dyloject Injection, has been accepted for formal review. The co expects to learn the Dyloject NDA's PDUFA date from the FDA in the next few weeks. The NDA is in support of US marketing approval and registration of Dyloject for the management of acute moderate-to-severe pain in adults.