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Nolvadex generic distribution by Barr to end

Executive Summary

Barr's distribution of "authorized" Nolvadex generic will not extend through AstraZeneca's pediatric exclusivity, which began Aug. 20. Barr will distribute its remaining inventories, but the end of discussions on an extension raises possibility the brand could be the only product on the market until exclusivity expires in February. Barr and FDA continue to negotiate the company's right to launch its own tamoxifen during pediatric exclusivity in light of tentative approval granted before passage of pediatric exclusivity legislation (1"The Pink Sheet" Aug. 19, p. 12)...
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