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WARRINGTON, Pa. - Discovery Laboratories Inc. said Tuesday it is still waiting for word from the Food and Drug Administration about review guidelines and timelines for its drug candidate Surfaxin.
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Discovery said it expected to know by Friday what review classifications the agency had in mind for the drug, and what the FDA's target action date would be. The agency asked Discovery for more information about the drug in May, and the company responded in September.
The company expected the FDA would take 60 days to review its latest application. It said it will provide another update after it receives the FDA's response.
Surfaxin is designed to treat respiratory distress syndrome in infants, and Discovery Labs has been seeking FDA approval for the drug for more than two years. Most recently, the agency asked Discovery to tighten the criteria for impurities in the manufacturing of Surfaxin, and provide more information about the drug.
Discovery shares slipped 5 cents, or 2.7 percent, to $1.82 in afternoon trading.
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