FDA issues complete response letter for roflumilast NDA

Forest Laboratories, Inc. (NYSE: FRX) and Nycomed today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roflumilast. Roflumilast was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations.

In the complete response letter the FDA requested certain additional information and analyses. No additional patient trials have been requested for the continued review of the NDA. Forest and Nycomed are committed to working with the FDA to address the outstanding matters and the companies anticipate a response to the FDA during the third calendar quarter of 2010.

SOURCE Nycomed and Forest Laboratories