Eurand Pharmaceuticals announced last week that the company had received an approvable letter from the FDA for its NDA for EUR-1008 (pancrealipase capsules) for the treatment of exocrine pancreatic insufficiency (EPI). The company did not state the FDA’s reasoning for the approvable status, but did say that the agency was not requiring additional clinical trials. The letter comes after what the company termed a successful pre-approval inspection of its manufacturing facilities.
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