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Wyeth withdraws pain product application from EMA review

This article was originally published in The Tan Sheet

Executive Summary

Wyeth Consumer Healthcare withdraws its centralized marketing authorization application for ibuprofen/diphenhydramine hydrochloride 200 mg/ 25 mg soft capsules, the European Medicines Agency announces Jan. 15. The agency says Wyeth withdrew the application because the Committee for Medicinal Products for Human Use concluded the data submitted does not support a positive benefit-risk balance for the analgesic and sedating antihistamine combination to be used by adults whose pain keeps them awake. Wyeth applied for marketing authority for the product Dec. 4, 2008, and withdrew it while under review by CHMP
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