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EC competition clears advisory panel

This article was originally published in The Tan Sheet

Executive Summary

FDA's Advisory Committee for Reproductive Health Drugs June 17 votes unanimously in favor of approving Watson Pharmaceuticals' emergency contraceptive ulipristal acetate, marketed in Europe as ellaOne by HRA Pharma. Collins Stewart analyst Louise Chen said in a same-day note the panel's decision bodes well for FDA approval and a likely early 2011 launch for UPA, which Chen expects to compete with Teva's Plan B One-Step (levonorgestrel). Although UPA would be available Rx-only upon approval, Watson CEO Paul Bisaro has stated an interest in switching the next-generation EC to nonprescription status (1"The Tan Sheet" March 15, 2010, In Brief)

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