Forest Laboratories and Cypress Bioscience : FDA Defers Final Action on milnacipran New Drug Application

Oct 20, 2008 - Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) (the "Companies") announced that the U.S. Food and Drug Administration (FDA) has advised the Companies that it was not able to take final action by the scheduled Prescription Drug User Fee Act action date of October 18, 2008, on their New Drug Application for milnacipran, a selective serotonin and norepinephrine reuptake inhibitor for the management of fibromyalgia.

The FDA has not requested any additional information from the Companies but did indicate that a clinical data question related to the NDA submission required confirmation. The FDA indicated that their assessment could be completed in a matter of weeks, but could not confirm specific timing. The FDA could not provide further information as to the reason for the delay. The Companies continue to plan for a first quarter 2009 product launch meeting... Forest Laboratories' Press Release - [PDF] Cypress Bioscience's Press Release -