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Barr tamoxifen ANDA must wait

Executive Summary

FDA says Barr cannot market generic Nolvadex (tamoxifen) before AstraZeneca's pediatric exclusivity expires Feb. 20. Barr's ANDA was tentatively approved before pediatric exclusivity law passed in 1997, and company's "authorized" distribution agreement expired in August (1"The Pink Sheet" Sept. 2, In Brief)..

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