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# Tentative OK for Upsher-Smith's XR Migraine Drug
- URL: https://www.fdaweb.com/tentative-ok-for-upsher-smiths-xr-migraine-drug/
- Published: 2016-06-10T12:00:00.000Z
- Updated: 2026-09-14T21:08:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135914

FDA has granted tentative approval to Upsher-Smith Laboratories for its supplemental NDA for Qudexy XR (topiramate) extended-release capsules for use as prophylaxis of migraine headache in adults. Company chief scientific officer William Pullman says that there are no extended-release topiramate formulations approved for migraine prophylaxis in the U.S. The drug is currently approved for use as initial monotherapy in patients two years of age and older with partial-onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients two years of age or older with partial-onset or primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome.