Barr generic tamoxifen
Executive Summary
Barr expects answer from FDA in mid-September regarding its right to manufacture generic tamoxifen. Barr is distributing an "authorized" generic of Nolvadex under license from AstraZeneca, and the generic company claims it is entitled to launch its own version before the brand's pediatric exclusivity expires in February. Barr may exhaust its existing inventory of tamoxifen in early November according to one estimate; it appears unlikely AstraZeneca will extend the supply agreement through the pediatric exclusivity period (1"The Pink Sheet" Aug. 26, In Brief)...
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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)..
Nolvadex generic distribution by Barr to end
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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