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J&J Concerta/methyphenidate adverse events

Executive Summary

FDA's Pediatric Advisory Committee will devote a full day to reviewing reports of adverse events with Johnson & Johnson's Concerta and other methylphenidate products on June 30. On June 29, the committee will review adverse event reports for ethinyl estradiol, J&J's Ortho Tri-Cyclen, Bayer's Cipro, Pfizer's Detrol LA, Sanofi-Aventis' Arava, Abbott's Zemplar, AstraZeneca's Zomig and Merck's Trusopt. The committee will also review the Pediatric Ethics Subcommittee's recommendation on a study protocol in newborns on June 29 (see following item). The meeting will be held at the CDER advisory committee conference room at 5630 Fishers Lane in Rockville, Md. beginning at 12:30 p.m. on June 29 and 8 a.m. on June 30 [Editor's Note: To 1watch a webcastor order a video/DVD of this meeting, visit]...

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