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.”