UPDATE 1-Forest, Cypress fibromyalgia drug delayed at FDA

BOSTON, Oct. 20 (Reuters) - Forest Laboratories Inc (FRX.N) and Cypress Bioscience Inc (CYPB.O) said on Monday the U.S. Food and Drug Administration was not able to make a decision on whether to approve their fibromyalgia drug by the scheduled date.

The agency was scheduled to take final action under the Prescription Drug User Fee Act by Oct. 18. The companies said the FDA has not requested any additional information from the companies but did indicate that a clinical data question related to the filing required confirmation.

The companies said the FDA indicated its assessment could be completed in a matter of weeks, but could not confirm the specific timing. The companies said the FDA could not provide further information as to the reason for the delay.

The companies said they continue to plan for a first quarter 2009 launch meeting of the drug, milnacipran. (Reporting by Toni Clarke, editing by Dave Zimmerman)