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Consumer OTC Drugs

Novopharm seeks ranitidine 75 mg expedited ANDA review, Torpharm petition dismissal.

This article was originally published in The Tan Sheet

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  • The Tan Sheet

Executive Summary

NOVOPHARM SEEKS EXPEDITED RANITIDINE 75 MG ANDA REVIEW by FDA in a citizen petition filed Aug. 7 in anticipation of the end of marketing exclusivity for Warner-Lambert's Zantac 75 OTC acid blocker on Dec. 19. Novopharm maintains it was the first to file an ANDA with Paragraph IV certification for generic ranitidine 75 mg. Therefore, the firm not only wants FDA's prompt consideration of its petition but also an agency dismissal of a July petition by competitor Torpharm seeking to deny Novopharm 180 days of exclusivity ("The Tan Sheet" July 27, p. 15).

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