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Qudexy XR FDA Approval History

FDA Approved: Yes (First approved March 11, 2014)
Brand name: Qudexy XR
Generic name: topiramate
Dosage form: Extended-Release Capsules
Company: Upsher-Smith Laboratories Inc.
Treatment for: Seizures, Lennox-Gastaut Syndrome, Migraine Prevention

Qudexy XR (topiramate) is an antiepileptic drug indicated for the treatment of partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut Syndrome in adults and children; and for the prophylaxis of migraine headache in adults and adolescents.

Development timeline for Qudexy XR

Mar 30, 2017Approval FDA Approves Expanded Indication for Qudexy XR (topiramate) Extended-Release Capsules to Include Prophylaxis of Migraine Headache in Adults and Adolescents
Jun  1, 2015Approval FDA Approves Expanded Indication for Qudexy XR (Topiramate) for Pediatric Patients
Mar 12, 2014Approval Upsher-Smith Receives FDA Approval for Qudexy XR (topiramate) Extended-Release Capsules

Further information

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