Discovery Labs works with FDA to clear up Surfaxin issues

6/20/2008

WARRINGTON, Pa. Discovery Laboratories and the Food and Drug Administration had a teleconference call Wednesday to discuss the key remaining items on the FDA’s May 1 approvable letter for Discovery Labs’ drug Surfaxin.

Surfaxin, known generically as lucinactant, is used to prevent respiratory distress syndrome in premature babies.

Discovery Labs said it could submit a formal response to the letter in September and that the FDA may designate the response as a Class 1 resubmission, meaning that the FDA would review it within 60 days.

Discovery Labs received the approvable letter May 1. The letter requested additional information for two items. One item requires more biological activity test data for the drug, while the other requires justifying proposed specifications for impurities in the drug’s individual active ingredients.

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