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news.Eurand has received an approvable letter from the FDA for its new drug application for EUR-1008 for the treatment of exocrine pancreatic insufficiency.
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The letter marks notable progress towards gaining approval and does not require Eurand to conduct additional clinical trials prior to approving EUR-1008. In addition, the FDA recently completed a successful pre-approval inspection of the company’s manufacturing facilities.
Eurand is working with the FDA to provide a full and timely response to the agency’s requests, and anticipates that it will be in a position to launch EUR-1008 in the second half of 2008.
Gearoid Faherty, CEO of Eurand, said: “We are pleased with the FDA’s conclusion that EUR-1008’s new drug application is approvable and look forward to cooperating with the agency’s requests.”