Pepcid AC
This article was originally published in The Tan Sheet
Executive Summary
J&J/Merck receives second "approvable" designation from FDA June 21 for a 10 mg hard-coated gelcap version of its OTC H2 antagonist (famotidine). FDA first deemed the product approvable in a Sept. 30 letter, but outstanding issues involving labeling subsequently developed
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J&J/Merck receives second "approvable" designation from FDA June 21 for a 10 mg hard-coated gelcap version of its OTC H2 antagonist (famotidine). FDA first deemed the product approvable in a Sept. 30 letter, but outstanding issues involving labeling subsequently developed. |