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Weiss inquiry into OTC promethazine

Executive Summary

FDA has reportedly sent documents related to its approval of the Rx-to-OTC switch of promethazine (Wyeth-Ayerst's Phenergan) to the House Government Operations/Intergovernmental Relations Subcommittee in response to a request for information from subcommittee Chairman Weiss (D-N.Y.). Public Citizen's Health Research Group petitioned FDA to ban OTC sales of promethazine-based products because of reported association with sudden infant death syndrome. Weiss' group frequently follows up on allegations of drug safety problems. FDA's Pulmonary-Allergy Drugs Advisory Committee concluded at its July 31 meeting that promethazine's Rx-to-OTC switch should not be allowed by FDA ("The Pink Sheet" Aug. 7, p. 10). Reportedly, Wyeth-Ayerst's parent American Home Products sent a letter to FDA that sharply criticizes the committee's conclusions.
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PS016155

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