FDA pushes back approval on fibromyalgia drug

BOSTON The Food and Drug Administration will not be able to approve a drug for fibromyalgia on time, the two companies making the drug said Monday.

The FDA was supposed to reach a final decision on Forest Laboratories and Cypress Bioscience’s drug milnacipran by Oct. 18, under the Prescription Drug User Fee Act. It did not request additional clinical data or other information from the two companies.

Forest and Cypress still plan to release the drug in 2009.