Forest files response to FDA Complete Response Letter for roflumilast NDA

Sep 13 2010

Forest Laboratories, Inc. (NYSE: FRX) today announced that it has filed a response to the U.S. Food & Drug Administration (FDA) addressing topics raised in the complete response letter regarding the New Drug Application (NDA) for roflumilast. Forest licenses roflumilast from Nycomed, which submitted the original NDA. The FDA has acknowledged receipt of the resubmission and considers it a complete, class 2 response to their May 17, 2010 complete response letter which requested certain additional information and analyses of existing data. No additional patient trials were requested.

Roflumilast is being reviewed as a potential treatment to reduce chronic obstructive pulmonary disease (COPD) exacerbations associated with chronic bronchitis in patients at risk for exacerbations. Forest expects a response from the FDA in the first quarter of calendar year 2011.

SOURCE Forest Laboratories, Inc.