MAPLE GROVE, Minn. — Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.
Qudexy XR will be available to patients in second quarter 2014.
Qudexy XR is indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures or primary generalized tonic-clonic seizures. It also is approved as adjunctive therapy in patients 2 years of age and older with POS, primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome.
"Upsher-Smith is pleased by the FDA's approval of Qudexy XR," stated Mark Evenstad, president and CEO of Upsher-Smith. "Today's approval is a major milestone in Upsher-Smith's history, as Qudexy XR is the first branded product in our central nervous system portfolio. At Upsher-Smith, our mission is to make a measurable improvement in people's lives by focusing on the patient."
Qudexy XR is available in 25-mg, 50-mg, 100-mg, 150-mg, and 200-mg extended-release capsules.