Published in Medical Letter on the CDC and FDA, November 18th, 2007
The filing of the NDA represents a progression in a series of recent milestones relating to BDSI's lead product, including the April 2007 announcement that BEMA Fentanyl met the primary efficacy endpoint in its placebo controlled study for breakthrough cancer pain and the recent announcement of a U.S. commercialization partnership with Meda AB.
The FDA will now have sixty days in which...
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