FDA Bolsters Warning On Phenergan Labeling At Urging Of Plaintiff's Attorney
This article was originally published in The Pink Sheet Daily
Executive Summary
Counsel for plaintiff in Wyeth v. Levine asked FDA to review the drug labeling after the Supreme Court's ruling in the case; the agency concluded the risk of severe tissue injury should be highlighted.
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FDA's recent requirement for stronger labeling of Phenergan (promethazine) reinforces the message from the Supreme Court in Levine v. Wyeth that finding a pattern of risk warrants label revisions, according to Wyeth's Chief Regulatory Counsel for Pharmaceuticals Geoffrey Levitt
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