Lupin Receives U.S. FDA Approval for Famotidine Injection USP
Lupin Limited received U.S. FDA approval for Famotidine Injection USP. The drug is bioequivalent to Pepcid® Injection and will be manufactured in India. Famotidine Injection had estimated U.S. sales of USD 8.7 million in March 2026.
FDA approval is significant for a pharmaceutical company as it allows market entry for a new product. The estimated annual sales of USD 8.7 million suggest a moderate but not overwhelming financial impact.
The U.S. FDA approval for a new drug product is a positive development for the company, indicating progress in its product pipeline and market expansion.
Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Applications (ANDAs) for Famotidine Injection USP, 20 mg/2 mL (10 mg/mL), Single-Dose Vials.
Famotidine Injection USP is bioequivalent to the reference listed drug, Pepcid® Injection. It is indicated for intravenous use in certain hospitalized patients with pathological hypersecretory conditions or intractable ulcers. It can also serve as a short-term alternative to oral medication for active duodenal ulcers, active benign gastric ulcers, gastroesophageal reflux disease (GERD), maintenance therapy for duodenal ulcers, and pathological hypersecretory conditions like Zollinger-Ellison Syndrome.
This product will be manufactured at Lupin's facility in Nagpur, India. The estimated annual sales for Famotidine Injection in the U.S. were USD 8.7 million as of March 2026 (IQVIA MAT March 2026).
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