Forest Labs (FRX) and Cypress Bioscience (CYPB) Announce FDA Defers Final Action on Milnacipran NDA
Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) today announced that the U.S. 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.
Cypress Bioscience, Inc. develops and commercializes pharmaceutical products and personalized medicine laboratory services to rheumatologists in the United States.
Forest Laboratories, Inc., together with its subsidiaries, develops, manufactures, and sells branded and generic forms of ethical drug products, and non-prescription pharmaceutical products.
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