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Qudexy XR 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 History and FDA Approval Process for Qudexy XR

DateArticle
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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