Resources for Food and Drug Administration (FDA)

Discovery Labs gets approvable letter from FDA for Surfaxin

www.hemscott.com

Discovery Laboratories Inc. said Monday that it received an approvable letter from the Food and Drug Administration for Surfaxin, its treatment for the prevention of respiratory distress syndrome in premature infants, and that it could file a response with the FDA in six to eight weeks.

The company said it believes the steps required to file a response to the approvable letter may be completed within that time and that the response may potentially be designated by the FDA as a class one resubmission with a review target of 60 days.

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