Lupin Receives U.S. FDA Approval for Famotidine Injection, USP.
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Lupin Limited has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Famotidine Injection USP, 20 mg/2 mL. The injection is bioequivalent to Pepcid® Injection from Merck Sharp & Dohme Corp. and is used to treat conditions like duodenal ulcers, gastric ulcers, GERD, and hypersecretory conditions like Zollinger-Ellison Syndrome. The product will be manufactured at Lupin's Nagpur facility in India. Famotidine Injection had estimated annual sales of USD 8.7 million in the U.S. market as per IQVIA data for the 12 months ending March 2026.
This FDA approval allows Lupin to launch a generic version of a well-established injectable drug in the U.S. market, potentially capturing market share in the ~$8.7 million annual segment. It strengthens Lupin's U.S. generics portfolio and could contribute positively to revenue over time.