OTC Loperamide Cardiovascular Label Warnings In US Spread To Perrigo Products

FDA approval for Perrigo's ANDA for two loperamide products listed as tablets follows CBE label changes Johnson & Johnson and BionPharma made for their branded OTCs containing the ingredient in 2019.

OTC Regulatory Decisions Tracker US

Editor's note: HBW Insight’s ongoing feature provides information on decisions during June by the US Food and Drug Administration on new drug applications, including ANDAs, for nonprescription drugs and on supplemental NDAs about label and package changes for approved OTC products.

Label changes approved in the US during June for Perrigo Company PLC’s OTC loperamide diarrhea remedies signal additional “changes...

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