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

SURFAXIN is to satisfy the FDA's requirements for final validation of the BAT. With the benefit of several interactions with the FDA, Discovery Labs completed a comprehensive preclinical program intended to meet the FDA's requirements.  Data from the comprehensive preclinical program was included in Discovery Labs' Complete Response for SURFAXIN filed with the FDA on September 2, 2011.  

DISCLOSURE NOTICE:  The information in this press release includes certain "forward-looking" statements, including statements about the remaining steps to potentially gain FDA approval of SURFAXIN for the prevention of RDS in premature infants and the timing of the anticipated FDA review period.  The final results of these and other related activities could vary materially from Discovery Labs' expectations and could adversely affect the chances for approval of SURFAXIN for the prevention of RDS in premature infants.  These activities and the ultimate outcomes are subject to a variety of risks and uncertainties, including but not limited to risks that (i) although the FDA guidance indicates that the FDA will complete its review of the NDA within six months after receipt of the submission, the FDA may not complete its activities within this time frame, (ii) although Discovery Labs believes that it has been successful in generating the additional data and other information requested by the FDA, the FDA may not be satisfied and may require Discovery Labs to perform further studies or undertake other activities that are presently not contemplated by Discovery Labs, (iii) the FDA may not be satisfied with (A) Discovery Labs' responses to other items identified in the 2009 Complete Response Letter, or (B) the results of anticipated pre-approval inspections of Discovery Labs' manufacturing and analytical facilities and the facilities of third party laboratories and manufacturers of active pharmaceutical ingredients (APIs) and other mate
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SOURCE Discovery Laboratories, Inc.
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