Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer and
marketer of specialty pharmaceutical products for pain management, today
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 been accepted for formal review. The Company 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.
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.
“Acceptance by the FDA of Javelin’s comprehensive NDA submission for
Dyloject marks a significant regulatory milestone towards our goal of
commercialization of Dyloject in the U.S. My colleagues and I are proud
of this major achievement and are committed with Javelin’s merger
partner, Myriad Pharmaceuticals, Inc. to developing and commercializing
new alternatives for patients suffering from acute moderate-to-severe
pain. We look forward to working with the FDA to facilitate the review
of the Dyloject NDA,” stated Eric Lang, MD, VP Clinical Research of
Javelin Pharmaceuticals, Inc.