On October 1st, I wrote a post on how there was a possible third Fibromyalgia drug in the works of being FDA approved (see my post HERE). Karen Richards on Chronic Pain Connection reported yesterday that the FDA has informed Forest Laboratories, Inc. and Cypress Bioscience, Inc. they were not able to take final action by the scheduled action date of October 18, 2008 on the New Drug Application for milnacipran. Karen writes:
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.
Cypress Bioscience and Forest Labs are still planning for a 2009 product launch meeting during the first quarter of the year.