Upsher-Smith announced that the Food and Drug Administration (FDA) has given final approval of 2 supplemental New Drug Applications (sNDAs) for Qudexy XR (topiramate) extended-release capsules for use as prophylaxis of migraine headache in adults and children aged ≥12 years.
Qudexy XR, a broad-spectrum antiepileptic, is already approved for use as initial monotherapy to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children aged ≥2 years; and as adjunctive therapy to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children aged ≥2 years.
The FDA granted tentative approval of the sNDAs in April 2016. A study to evaluate the efficacy and safety of Qudexy XR for use as prophylaxis of migraine in pediatric patients aged 6-11 years is planned.
Qudexy XR is available as 25mg, 50mg, 100mg, 150mg, and 200mg strength extended-release capsules.
For more information call (855) 282-4887 or visit QudexyXR.com.