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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