Endo’s Frova Delayed on New-Use Approval

U.S. firms Endo and Vernalis said Friday the Food and Drug Administration has extended by three months an application for Frova’s expanded use.

The companies said the Food and Drug Administration has notified them it would require another three months to review Endo’s supplemental new drug application, in which Endo is seeking approval on a new use for Frova, for the short-term prevention of menstrual migraine.

With the extension, the FDA is expected to complete its review of the application on or before Aug. 19, the companies said.

FDA’s need for extra review time is related to the presentation of the data, rather than its content and the agency did not request additional information, the companies stressed.

Endo President and CEO Peter Lankau said the extended review time would have no effect on the company’s 2007 financial guidance.

Frova was previously approved for the acute treatment in adults of migraine attacks with or without aura, or subjective symptoms at the onset of a migraine.