30-month stay of ANDA approval for Mylan generic version of Zeneca's Nolvadex ends July 10, Barr says in petition filed with FDA. Barr maintains it is entitled to first-to-file exclusivity for tamoxifen, arguing that approval of Mylan's ANDA must wait until 180 days after Barr's commercial marketing under its own ANDA or a court ruling on the patent. Barr markets an "authorized" generic version of tamoxifen sourced from Zeneca under a patent suit settlement. The firm's argument is based on FDA's recent elimination of the "successful defense" requirement for generic exclusivity ("The Pink Sheet" June 29, p. 26)
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