The US Food and Drug Administration (FDA) has granted tentative approval for Upsher-Smith Laboratories' supplemental new drug application (sNDA) for Qudexy XR (topiramate) extended-release capsules for use as prophylaxis of migraine headache in adults.
"Topiramate is the molecule prescribed most frequently by neurologists for the prevention of migraines. However, there are currently no extended-release topiramate formulations approved for migraine prophylaxis in the US," said William Pullman, MB, BS, BMedSc, PhD, FRACP, chief scientific officer and Biotech Research Institute Division President, Upsher-Smith. "We look forward to bringing this treatment option to the migraine community, and will continue to work with the FDA to gain final approval."
Qudexy XR is currently approved for use as initial monotherapy in patients two years of age and older with partial-onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients two years of age or older with partial-onset or primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Qudexy XR has been available in the United States since June 2014.
Qudexy XR (topiramate) extended release capsules is a prescription medicine used to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) and with other medicines 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 2 years and older.
Upsher-Smith Laboratories, Inc., founded in 1919, is a growing, fully integrated pharmaceutical company dedicated to its mission of delivering high-value, high-quality therapies and solutions which measurably improve individuals' lives.