Posted by Michael Wonder on 31 Mar 2017
FDA approves expanded indication for Qudexy XR (topiramate) extended release capsules to include prophylaxis of migraine headache in adults and adolescents
30 March 2017 - Molecule most prescribed by neurologists for migraine prophylaxis now available in a unique 24 hour formulation.
Upsher-Smith Laboratories today announced that it has received U.S. FDA final approval of two supplemental new drug applications (sNDAs) for Qudexy XR (topiramate) extended release capsules for use as prophylaxis of migraine headache in adults and adolescents 12 years of age and older.
Topiramate is the molecule that neurologists prescribe most frequently for the prevention of migraines, and the American Academy of Neurology and the American Headache Society have given topiramate a "top tier" rating for migraine prevention in adults.
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 paediatric patients ages 6-11. 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.
