Qudexy
Drug - Qudexy™ XR (topiramate capsule, extended-release) [Upsher-Smith Laboratories, Inc.]
November 2014
Therapeutic area - Anticonvulsants
FDA approved indications
- Qudexy XR is approved as initial monotherapy in patients 10 years of age or older with partial onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures
- Qudexy XR is approved in patients 2 years of age or older as adjunctive therapy with seizures associated with Lennox-Gastaut syndrome
Approval criteria
- Patient is 2 years of age or older AND
- Patient has one of the following diagnoses: partial onset seizures; primary generalized tonic/clonic seizures; Lennox-Gastaut syndrome AND
- Patient has had a two-month trial of immediate-release topiramate
Background information
Qudexy™ XR is only indicated for treatment of specific seizure disorders. Appropriate diagnosis of seizures will be required for approval; use in migraines, neuralgia or bipolar disorder will not be approved.
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
