Torpharm Petition To Block Novopharm Generic Ranitidine Exclusivity Denied
This article was originally published in The Tan Sheet
Executive Summary
Torpharm's citizen petition asking FDA to deem no ANDA applicant for a generic 75 mg ranitidine product is entitled to 180 days of generic drug Waxman/Hatch marketing exclusivity was denied by FDA in a Dec. 4 letter to the firm.