Country-specific information on topiramate
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Johnson & Johnson Pharmaceutical Research and Development reported on 18 November 2003 that the US FDA issued an approvable letter for the use of topiramate (TOPAMAX) in the prophylaxis of migraine in adults.
A supplemental NDA filing for topiramate in this indication was submitted on 20 December 2002. The FDA did not request any additional studies and the company is to respond to the letter.
Topiramate, an AMPA antagonist and GABA agonist, is marketed worldwide as an adjunctive therapy for partial seizures and is also approved in Mexico, Thailand, Portugal, and the Philippines for the indication of migraine prophylaxis. alpha-amino-3-hydroxy-5-methylisoxazole-4-proprionic acid Food and Drug Administration Food and Drug Administration gamma aminobutyric acid new drug application new drug application new drug application new drug application new drug application
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