Lupin has received U.S. FDA approval for its generic Famotidine Injection USP, 20 mg/2 mL single-dose vials, referencing Merck’s Pepcid Injection.
Written By: Regulatory Desk
Lupin Limited announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Famotidine Injection USP, 20 mg/2 mL (10 mg/mL), supplied in single-dose vials.
The approved product is bioequivalent to the reference listed drug, Pepcid Injection, 10 mg/mL. Famotidine is a histamine-2 receptor antagonist used to reduce stomach acid production.
Famotidine Injection is indicated for intravenous use in certain hospitalized patients with pathological hypersecretory conditions or intractable ulcers. It may also be used as a short-term alternative to oral therapy in patients unable to take oral medications.
Approved indications include the short-term treatment of active duodenal ulcer, active benign gastric ulcer, gastroesophageal reflux disease (GERD), maintenance therapy for healed duodenal ulcer patients at a reduced dosage, and treatment of pathological hypersecretory conditions such as Zollinger-Ellison syndrome and multiple endocrine adenomas.
According to the company, the product will be manufactured at Lupin’s facility in Nagpur, India.
IQVIA MAT March 2026 data showed that Famotidine Injection recorded estimated annual U.S. sales of approximately USD 8.7 million.
Reference
Lupin Receives U.S. FDA Approval for Famotidine Injection, USP – Lupin | Press Release
