Generic Famotidine Launch Delayed By Pepcid AC Pediatric Exclusivity
This article was originally published in The Tan Sheet
Executive Summary
Private label famotidine 10 mg products will not launch until after April 15 due to FDA's Nov. 21 decision to grant J&J/Merck an additional six months of marketing exclusivity for Pepcid AC after reviewing pediatric data submitted by the firm.
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Pediatric Exclusivity Could Be Out-Licensed To Other Sponsors, FDA Suggests
Congress should consider allowing pediatric exclusivity periods to be licensed to other sponsors as a mechanism for promoting pediatric study of drug products that do not have patent protection or exclusivity, FDA's pediatric exclusivity status report suggests.
Pediatric Exclusivity Could Be Out-Licensed To Other Sponsors, FDA Suggests
Congress should consider allowing pediatric exclusivity periods to be licensed to other sponsors as a mechanism for promoting pediatric study of drug products that do not have patent protection or exclusivity, FDA's pediatric exclusivity status report suggests.