FDA Approves Expanded Indication For Qudexy XR Extended Release Capsules

Thursday, March 30, 2017 | FDA Approval/Clearance , Pain & Headache


The FDA has approved two supplemental indications for Qudexy XR (topiramate, Upsher-Smith) Extended Release Capsules for use as prophylaxis of migraine headache in adults and adolescents 12 years of age and older. Qudexy XR capsules offer adolescents and adults with migraines a once-daily prophylactic medication that can be taken morning or night, with or without food. The capsules have also been approved for administration by opening and sprinkling the contents onto a small amount of soft food, which may be helpful to patients who have difficulty swallowing whole capsules.

Upsher-Smith was granted tentative approval of its sNDA in April 2016, but was not eligible to receive final approval until after the innovator drug’s exclusivity for the adolescent population expired in March 2017. 

A study designed to address post-marketing requirements in the United States is planned to evaluate the efficacy and safety of Qudexy XR for the prophylaxis of migraine in pediatric patients ages 6-11.

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