Zantac 75 EFFERdose approval dependent upon minor label changes.
This article was originally published in The Tan Sheet
Executive Summary
ZANTAC 75 EFFERDOSE FIRST OTC EFFERVESCENT H2 ANTAGONIST to be approved by FDA. Glaxo Wellcome's NDA (20-745) for the effervescent tablet form of 75 mg ranitidine cleared the agency Feb. 26. Glaxo received an "approvable" letter for the effervescent dosage form of the heartburn remedy July 8 ("The Tan Sheet" July 28, 1997, p. 8). The NDA was filed in July 1996. Warner-Lambert markets Zantac 75 under a joint venture arrangement for Glaxo's Rx-to-OTC switch products.
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