The FDA approved 2 supplemental new drug applications (sNDAs) for Upsher-Smith Laboratories’ Qudexy XR (topiramate) extended-release capsules, expanding the drug’s indication for use as prophylaxis of migraine headaches in adults and adolescents aged 12 years and older.
Qudexy XR capsules are a once-daily prophylactic medication for adolescents and adults that can be taken morning or night, with or without food. It has also been approved for administration by opening and sprinkling contents onto food for patients who may have difficulty swallowing capsules.
Qudexy XR is also approved for use as initial monotherapy and adjunctive therapy in patients 2 years of age and older with partial-onset or primary generalized tonic-clonic seizures.
A study is set to evaluate the efficacy and safety of Qudexy XR for the prophylaxis of migraine in pediatric patients aged 6-11 years old.
Upsher-Smith was granted tentative approval by the FDA for its sNDA in April 2016.
FDA approves expanded indication for Qudexy XR (topiramate) extended-release capsules to include prophylaxis of migraine headache in adults and adolescents [news release]. Minnesota. Upsher-Smith’s website. http://www.upsher-smith.com/wp-content/uploads/112336.01-QXR-PR-Migraine-Launch-FINAL-for-Website.pdf
. Accessed Apr. 3, 2017.