J&J/MERCK OTC FAMOTIDINE SWITCH STALLS
This article was originally published in The Tan Sheet
J&J/MERCK OTC FAMOTIDINE SWITCH STALLS due to statistical concerns related to the company's efficacy data analysis that emerged during a review of the switch application by FDA's Nonprescription Drugs and Gastrointestinal Drugs Advisory Committees on July 29. The joint committee unanimously agreed that FDA and the sponsor must resolve issues concerning the statistical analyses and design of the famotidine (Pepcid) studies before the product is approved for OTC use.
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