FDA delays decison on Forest/Cypress' milnacipran

Forest Laboratories and fellow USA-based Cypress Bioscience have been told by US Food and Drug Administration that it will not be able to meet the October 18 deadline for a decision on the New Drug Application for milnacipran, their 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 agency indicated that its 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 and the companies continue to plan for a product launch meeting in the first quarter of next year.