Lupin Gets US FDA Nod for Famotidine Injection, USP

Lupin Ltd. has received U.S. FDA approval for its Abbreviated New Drug Application for Famotidine Injection USP, 20 mg/2 mL (10 mg/mL), Single-Dose Vials. The drug is bioequivalent to Pepcid® Injection and is indicated for intravenous use in hospitalized patients with hypersecretory conditions or intractable ulcers. It serves as an alternative to oral dosage forms for short-term treatment. 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. (IQVIA MAT March 2026).