FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Laboratories (DSCO)' Surfaxin
11/10/2008 6:53:41 AM
WARRINGTON, Pa., Nov 7, 2008 (GlobeNewswire via COMTEX) -- Discovery Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Discovery Labs' Complete Response for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The FDA has designated the Complete Response as a Class 2 resubmission and has established April 17, 2009 as its target action date under the Prescription Drug User Fee Act (PDUFA) to complete its review and potentially grant marketing approval for Surfaxin.
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