Apotex' ranitidine
This article was originally published in The Tan Sheet
Executive Summary
ANDA for OTC 75 mg ranitidine tablets tentatively approved by FDA Sept. 29. Exclusivity for the reference drug, Warner-Lambert's Zantac 75, expires Dec. 19. The agency letter does not make reference to Apotex' petition to deny private label competitor Novopharm 180 days of exclusivity for its private label ranitidine product, which the company theoretically might receive as the first to file for the OTC drug ("The Tan Sheet" July 27, p. 15). Novopharm responded with a petition requesting the exclusivity award as well as the dismissal of Apotex' petition ("The Tan Sheet" Aug. 24, p. 8). FDA notes Apotex' certification that its "manufacture, use, sale or offer to sell" the product will not infringe on Zantac patents expiring in June 2002 and May 2008. Other firms with tentative approval include Chelsea and Ranbaxy