Endo pulls Frova app after mulling FDA response

Tue, 08 Apr 2008 06:59:54 -0400

Endo Pharmaceuticals says a close reading of a non-approvable letter from the FDA for Frova prompted officials to pull their request to gain approval for the short-term relief of menstrual migraine. The Chadds Ford, PA-based developer has already won approval for the use of Frova against acute migraine for patients with a clear diagnosis. And without explanation Endo says it will return the rights to Chronogesic to Durect.

"The decision to withdraw the unapproved supplemental application was complex; however, after a lengthy and detailed evaluation of the points raised in the FDA 'not approvable' letter, we have determined the withdrawal to be the appropriate course of action at this time," said Endo CEO Dave Holveck (photo).

- here's the release
- read the report in the Philadelphia Business Journal

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