Barr tamoxifen ANDA must wait
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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Barr will be unable to supply tamoxifen 10 mg after mid-November in the absence of court action to overrule FDA and allow the immediate launch of the firm's generic
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)...
The AAM has warned the Trump administration that ‘Buy American’ requirements on medicines could limit patient access to affordable medicines and increase the risk of drug shortages during the coronavirus pandemic.