Last month I told you that a third drug may soon be approved for fibromyalgia. Today Forest Laboratories, Inc. and Cypress Bioscience, Inc. announced that the U.S. Food and Drug Administration has advised them that it was not able to take final action by the scheduled 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 but did indicate that a clinical data question related to the 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. Forest Labs and Cypress Bioscience are continuing to plan for a first quarter 2009 product launch meeting.
Although we're not going to see FDA approval of milnacipran as quickly as we had wished, hopefully by the first of the year we'll have a third FDA-approved option for treating fibromyalgia.
Published On: October 20, 2008