Zydus Lifesciences receives USFDA approval for Famotidine tablets

India Pharma Outlook Team | Tuesday, 07 June 2022

Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to

market Famotidine tablets in 20 mg and 40 mg strengths (USRLD: Pepcid). Famotidine is a histamine H2 receptor blocker. It works by reducing the amount of acid in the stomach. It is used to prevent and treat heartburn and other symptoms caused by excessive acid in the stomach (acid indigestion).

The drug will be manufactured at the group’s drug formulation facility at SEZ, Ahmedabad. As per IQVIA MAT April 2022, Famotidine Tablet has a market size of USD 67 mn.The group now has 315 approvals and has so far filed over 420 ANDAs since the commencement of the filing process in FY 2003-04.