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Discovery Labs Surfaxin update

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Discovery Labs is pushing back its launch plans for Surfaxin (lucinactant) to Q2 2006 due to additional information requested by FDA, the firm says Aug. 19. The company plans to respond within 60 days to a dozen questions from FDA regarding Surfaxin. Among the issues is a question regarding the stability test used by a supplier of one of Surfaxin's active ingredients. Discovery responded to a February "approvable" letter in July, but the response was not deemed complete. FDA "will allow us to amend [the response] with our response to these 12 items," CEO Robert Capetola says. Discovery is seeking an indication for use of Surfaxin in prevention of respiratory distress syndrome in premature infants...

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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