Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Applications for Famotidine Injection USP, 20 mg/2 mL (10 mg/mL), Single-Dose Vials.
Famotidine Injection USP, 20 mg/2 mL (10 mg/mL) is bioequivalent to the reference listed drug (RLD), Pepcid® Injection, 10 mg/mL of Merck Sharp & Dohme Corp. It is indicated for intravenous use in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the 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 (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas). This product would be manufactured at Lupin’s Nagpur facility in India.
Famotidine Injection had estimated annual sales of USD 8.7 million in the U.S. (IQVIA MAT March 2026).
