Surfaxin
Generic name: lucinactant
Treatment for: Respiratory Distress Syndrome
Discovery Labs Provides Update on Status of Response to FDA Approvable Letter for Surfaxin
WARRINGTON, Pa., August 19, 2005 -- Discovery Laboratories, Inc. (Nasdaq:DSCO) has received formal written notification from the U.S. Food and Drug Administration (FDA), following its review of the Company's previously submitted Response Letter, outlining select items that need to be addressed in order for the FDA to deem the response complete. The Company's Response Letter to the FDA's Approvable Letter for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants was previously submitted on July 29, 2005.
In its written notification, the FDA outlined twelve items, centered on chemistry and manufacturing, that require further clarification or additional information to support the Company's comprehensive response. These items are not related to the quality of the Surfaxin clinical trials or their results. Additionally, the items do not raise any new issues related to the Company's contract drug product manufacturer, Laureate Pharma, Inc. The Company is in the process of addressing these items and anticipates submitting its response to the FDA in October 2005. The approval of Surfaxin is now anticipated in April 2006 with commercial launch to occur in the second quarter of 2006.
Surfaxin is a precision-engineered, peptide-containing, synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant and represents a potential alternative for the animal-derived and non-protein containing synthetic surfactants. Discovery's Surfaxin has recently received an Approvable Letter from the FDA for the prevention of RDS in premature infants and is pending approval. Surfactants are substances that are produced naturally in the lungs and are essential to the lungs' ability to absorb oxygen and to maintain proper airflow through the respiratory system. Premature babies are born with a lack of natural surfactant in their lungs. Without surfactant, the air sacs in the lungs collapse and are unable to absorb sufficient oxygen resulting in RDS.
Source: Discovery Laboratories, Inc.
Posted: August 2005
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Surfaxin (lucinactant) FDA Approval History
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