Human Genome Sciences, Inc. HGSI -0.73% announced today that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for raxibacumab, a treatment for inhalational anthrax, and has established December 15, 2012 as the Prescription Drug User Fee Act (PDUFA) action date.
The FDA has deemed the resubmission a complete, class 2 response to its November 14, 2009 complete response letter, which requested further analyses of existing data as well as additional information.
To read the full, original article click on this link: Human Genome Sciences Announces Resubmission of Raxibacumab BLA to FDA - MarketWatch
