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Endo Pharma withdraws Frova application for menstrual migraine

Mon Apr 7, 2008 6:19pm EDT

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April 7 (Reuters) - Endo Pharmaceuticals Holdings Inc (ENDP.O) said it has withdrawn the supplemental new drug application to extend the use of its migraine drug Frova in short-term prevention of menstrual migraine.

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The decision to withdraw the application comes after an evaluation of the points raised in the "not approvable" letter issued by the U.S. Food and Drug Administration, the company said.

In September 2007, the FDA identified deficiencies and asked for more information regarding Frova for menstrual migraine prevention. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Deepak Kannan)

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