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news.Endo Pharmaceuticals and Vernalis have reported that the FDA has requested more time to review their supplemental new drug application for menstrual migraine drug Frova.
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The FDA indicated that it will provide a revised timeline to Endo and Vernalis, and the companies will make an announcement when appropriate. Until the companies receive further information from the FDA, they intend to continue with their existing commercial plan. The FDA has not currently requested any additional information or clinical trial data.
Frova is already approved for the treatment of migraines.