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( As on 13/05/2026 18:25)

Lupin Ltd gets USFDA approval for Famotidine Injection

Lupin Limited has received approval from the United States Food and Drug Administration for its abbreviated new drug application (ANDA) for Famotidine Injection USP, 20 mg/2 mL single-dose vials.

The approved product is bioequivalent to Pepcid Injection, 10 mg/mL, marketed by Merck Sharp & Dohme Corp..

Famotidine Injection is used in hospitalized patients for the treatment of conditions such as active duodenal ulcer, benign gastric ulcer, gastroesophageal reflux disease (GERD), pathological hypersecretory conditions including Zollinger-Ellison Syndrome, and as an alternative treatment for patients unable to take oral medication.

The product will be manufactured at Lupin’s Nagpur facility in India.

According to IQVIA data for March 2026, Famotidine Injection recorded estimated annual sales of around USD 8.7 million in the US market.