USA FDA seeks clarification on Discovery Labs' Surfaxin; issues briefing papers on GSK's Breo Ellipta

15 April 2013

US biotech firm Discovery Laboratories (Nasdaq: DSCO) says that the Food and Drug Administration has requested clarification and provided recommendations regarding the recently-updated product specifications for Surfaxin (lucinactant), used for the prevention of respiratory distress syndrome.

Discovery Labs plans to provide a response to the FDA within two months. Agency procedure provides up to four months for review of the information provided. If its plan is successful and the FDA agrees with the response, Discovery Labs expects to proceed with the commercial introduction of Surfaxin in the fourth quarter of 2013.

The recently-received FDA correspondence includes a request for specific information intended to clarify certain aspects of the updated product specifications and the revalidated analytical chemistry method, including:

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