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J&J Topamax labeling expansions

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Topiramate tablets and sprinkle capsules add indication Aug. 28 for adjunctive therapy for seizures associated with Lennox-Gastaut syndrome in patients two years and older. J&J's Topamax is the third anticonvulsant, after GlaxoSmithKline's Lamictal (lamotrigine) and Carter-Wallace's Felbatol (felbamate), indicated for Lennox-Gastaut syndrome. New labeling will also include a warning regarding acute myopia and secondary angle closure glaucoma, based on 23 reports of acute myopia/glaucoma as of Aug. 17. The company will send a "Dear Health Care Professional" letter detailing the myopia and glaucoma warning
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