J&J Topamax labeling expansions
This article was originally published in Pharmaceutical Approvals Monthly
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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