Lupin has received approval from the US 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.

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.

The injection is indicated for intravenous use in some hospitalised 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).

The product would be manufactured at Lupin’s Nagpur facility.