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Novopharm Entitled To OTC Ranitidine Generic Exclusivity - Federal Judge

This article was originally published in The Tan Sheet

Executive Summary

Novopharm is entitled to 180 days of generic marketing exclusivity for OTC ranitidine 75 mg, D.C. federal court Judge Emmet Sullivan rules June 15 in Apotex vs. Shalala. In his opinion, Sullivan upholds FDA's interpretation of the generic exclusivity provisions of the Waxman/Hatch Act.

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