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Effervescent ranitidine

This article was originally published in The Tan Sheet

Executive Summary

ANDA suitability petition for effervescent ranitidine product withdrawn by Budd Lake, N.J.-based regulatory consultant Thomas Blake, who had filed the petition on behalf of an unnamed client ("The Tan Sheet" Sept. 15, 1997, p. 14). FDA's recent approval of Warner-Lambert's Zantac Efferdose product "means, of course, that an ANDA would be appropriate for the drug," Blake says. Approval of the unnamed party's ANDA will depend on whether Waxman/Hatch exclusivity is granted to the effervescent Zantac product. Zantac Efferdose was approved Feb. 26 ("The Tan Sheet" March 2, p. 1). The agency has yet to disclose an exclusivity ruling...
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