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J&J Topamax “approvable” for migraines

Executive Summary

Johnson & Johnson plans to respond around year-end to an Oct. 23 "approvable" letter for Topamax (topiramate) for the supplemental indication of prophylaxis of migraine headache. Final approval awaits additional analysis of safety data and labeling negotiations...

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Topamax approved for migraine prevention

Ortho-McNeil's anti-convulsant Topamax (topiramate) clears FDA Aug. 11 for supplemental indication of prophylaxis of migraine headaches in adults. The recommended daily dose for migraines is 100 mg administered in two divided doses. Topamax' twice-daily migraine prevention regimen may place the drug at a disadvantage to Abbott's Depakote ER (divalproex extended-release), which has once-daily dosing . Ortho-McNeil received an "approvable" letter for the migraine indication in October 2003 (1"The Pink Sheet" Nov. 24, 2003, In Brief)...

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