Qudexy XR Gains New Migraine Indication

Qudexy XR is already approved for use as initial monotherapy to treat certain types of seizures
Qudexy XR is already approved for use as initial monotherapy to treat certain types of seizures

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. 

Related Articles

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.