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Daxas response accepted

September 14, 2010 12:47 AM UTC

FDA accepted a response from Forest Laboratories Inc. (NYSE:FRX) to a May complete response letter for Daxas roflumilast to treat chronic obstructive pulmonary disease (COPD). The agency designated the resubmission as a Class 2 response. Forest and partner Nycomed (Zurich, Switzerland) expect a decision in 1Q11. In April, an FDA panel voted 10-5 that safety and efficacy data do not provide substantial evidence to support the approval of the oral phosphodiesterase-4 (PDE-4) inhibitor. ...