New Migraine Indication for Qudexy XR

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Qudexy XR, a broad-spectrum antiepileptic, is already approved for use as initial monotherapy to treat certain types of seizures.
Qudexy XR, a broad-spectrum antiepileptic, 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. 

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.

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For more information call (855) 282-4887 or visit QudexyXR.com.

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