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

rials used in the manufacture of SURFAXIN, and, as a result, Discovery Labs may be unable to gain approval of SURFAXIN, if at all, within the time frame indicated above, (v) Discovery Labs may identify problems that have not yet been discovered, and (iv) the FDA could impose additional requirements to gain approval of SURFAXIN.  Any failure to satisfy the FDA's requirements could significantly delay, or preclude outright, approval of SURFAXIN, which could potentially prevent the approval of Discovery Labs' other products.

About Discovery Labs

Discovery Laboratories, Inc. is a specialty biotechnology company with one focus – to create life-saving products for patients with respiratory disease and improve the standard of care for pulmonary medicine.  Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, lyophilized and aerosol formulations. Discovery Labs is also developing its proprietary drug delivery technologies – capillary aerosol generator and novel patient interface adapters – to enable efficient, targeted upper respiratory or alveolar delivery of aerosolized KL4 surfactant.  Discovery Labs believes that its proprietary technology makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our website at www.discoverylabs.com.

Forward Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  These forward-looking
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SOURCE Discovery Laboratories, Inc.
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