Lupin gets FDA nod for famotidine injection to treat ulcers, GERD

Drug firm Lupin Ltd on Wednesday (May 13) said it has received approval from the United States Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for famotidine injection USP, 20 mg/2 mL (10 mg/mL), single-dose vials.

The product is bioequivalent to the reference listed drug (RLD), Pepcid injection, 10 mg/mL, manufactured by Merck Sharp & Dohme Corp.

Famotidine injection USP, 20 mg/2 mL (10 mg/mL) is indicated for intravenous use in certain hospitalised patients with pathological hypersecretory conditions or intractable ulcers. It is also used as an alternative to oral dosage forms for short-term use in patients who are unable to take oral medication.

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The drug is prescribed for short-term treatment of active duodenal ulcer, active benign gastric ulcer, gastroesophageal reflux disease (GERD), maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer, and treatment of pathological hypersecretory conditions such as Zollinger-Ellison Syndrome and multiple endocrine adenomas.

The product will be manufactured at Lupin’s Nagpur facility in India. Famotidine Injection had estimated annual sales of $8.7 million in the United States, according to IQVIA MAT March 2026 data.

Fourth quarter results

Lupin nearly doubled its consolidated net profit to ₹1,460 crore in the January-March quarter (Q4FY26), driven by strong performance in its United States generics business and broad-based revenue growth across markets. The Mumbai-based drugmaker’s revenue from operations rose 31.9% to ₹7,475 crore from ₹5,667 crore a year earlier.

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Profit for the quarter included a one-time exceptional cost of ₹131 crore. Excluding that, adjusted profit came in at ₹1,592 crore, still sharply higher than the ₹773 crore reported in the same quarter last year. For FY26, consolidated net profit rose 62.5% to ₹5,333 crore from ₹3,282 crore in FY25, while revenue grew 23.1% to ₹27,958 crore from ₹22,708 crore.

Shares of Lupin Ltd ended at ₹2,215.45, down by ₹30.55, or 1.36%, on the BSE today, May 13.