FDA grants tentative approval for Topiramate in migraine prophylaxis
Food and Drug Administration (FDA) has granted a tentative approval for topiramate to include prophylaxis of migraine headache in adults.
The tentative approval implies that FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but it is subject to pediatric exclusivity expiring March 28, 2017. The FDA's final approval will not be in effect until the exclusivity period has expired.
Additionally, FDA has granted final approval to expand the label for Topiramate for monotherapy of partial onset seizures to include adults and pediatric patients aged 6 years and older, instead of the 10 years and older age group. Topiramate is already indicated as initial monotherapy and adjunct in partial-onset or primary generalized tonic-clonic seizures and as adjunct in Lennox-Gastaut Syndrome. Topiramate is available as 25mg, 50mg, 100mg, and 200mg in the form of extended-release capsules.
FDA has also approved another extended-release formulation of Topiramate in June 2015 as initial monotherapy in patients with two years of age and older with partial onset or primary generalized tonic-clonic seizures.
It is indicated for initial or adjunctive therapy in certain patients with partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome. It was previously approved by the FDA on March, 2014.