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Discovery Labs Notified of PDUFA Date for SURFAXIN®
Date:9/28/2011

WARRINGTON, Pa., Sept. 28, 2011 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO) announced today that the U.S. Food and Drug Administration (FDA) has deemed "complete" the company's Complete Response for SURFAXIN® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.  The FDA classified the review of the Complete Response as a Class 2 review and established March 6, 2012 as the target action date under the Prescription Drug User Fee Act (PDUFA) to complete its review and potentially grant marketing approval for SURFAXIN.

If approved, SURFAXIN would represent the first synthetic, peptide-containing surfactant for use in neonatal medicine and provide healthcare practitioners with a potential alternative to the currently approved, animal-derived surfactants that today are the standard of care to manage RDS in premature infants.

Discovery Labs will hold a conference call today at 3:00 PM EDT to provide an overview of the SURFAXIN Complete Response filed with the FDA.  

Conference Call Details

A live webcast of the conference call, including a slide presentation, is available at https://us.reg.meeting-stream.com/surfaxin-update and www.discoverylabs.com. An archive of the webcast will be available on Discovery Labs Investor Relations web site for approximately 45 days.  

For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the dial-in numbers are (866) 332-5218 (U.S.) or (706) 679-3237 (international). The passcode for the call is 11540927.    

An audio replay of the conference call will be available two hours after the call's completion. The dial-in numbers for the replay are (855)
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SOURCE Discovery Laboratories, Inc.
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