Expanded Indication for Qudexy XR
June 2, 2015 – The U.S. Food and Drug Administration approved a new indication for Qudexy® XR (topiramate) extended-release capsules. Qudexy XR is now approved as a single-agent treatment of partial onset seizures and generalized tonic-clonic seizures. Qudexy XR is manufactured by Upsher-Smith Laboratories. Previously, the indication was limited to patients aged 10 years and older, however now Qudexy XR can be used as initial monotherapy for patients at least two years old. Once-daily Qudexy XR also has approval as add-on therapy to treat partial onset seizures, generalized tonic-clonic seizures and seizures related to Lennox-Gastaut syndrome for patients two years old and older.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.