FDA Approves Famotidine Injection USP Single-Dose Vials

The US Food and Drug Administration (FDA) has approved Lupin Pharmaceuticals’ Abbreviated New Drug Applications for Famotidine Injection USP, 20 mg/2 mL (10 mg/mL), Single-Dose Vials, bioequivalent to the reference listed drug (RLD), Pepcid Injection, 10 mg/mL of Merck Sharp & Dohme Corp.

As described in a May 13, 2026, press release from the Company, the product would be manufactured at Lupin's Nagpur facility in India.

Famotidine is a histamine-2 (H2) receptor antagonist that reduces gastric acid secretion and is used to treat gastrointestinal conditions associated with excess acid production. It is available both by prescription and over the counter (OTC).

The drug was developed in Japan and has been marketed since 1981 in the United States and elsewhere under the trade name Pepcid. Of note, the patents on famotidine expired in 2001, after which generic versions came onto the market.

Prescription indications for famotidine approved by the FDA include the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease (GERD) in adults and children, and pathological hypersecretory conditions in adults. OTC formulations are approved for the prevention and treatment of heartburn associated with GERD in both adult and pediatric populations.

According to the manufacturer’s package insert, famotidine is available in multiple formulations, including IV solution, oral suspension, and tablets in strengths of 10 mg, 20 mg, and 40 mg. Like its RLD, the now-approved 20 mg/2 mL (10 mg/mL) injection from Lupin 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, GERD, maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer and treatment of pathological hypersecretory conditions.

The decision comes on the heels of another approval granted to Lupin on May 5, 2026, for the Company’s Abbreviated New Drug Applications for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, which is bioequivalent to the reference listed drug, Ravicti Oral Liquid, 1.1 grams per mL, of Horizon Therapeutics. It is indicated for chronic management of patients with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone.

References

1. Lupin Pharmaceuticals. Lupin Receives U.S. FDA Approval for Famotidine Injection, USP. May 13, 2026. Accessed May 13, 2026. https://www.prnewswire.com/news-releases/lupin-receives-us-fda-approval-for-famotidine-injection-usp-302771378.html

2. Patel P, Ahlawat R. Famotidine. StatPearls. September 14, 2025. Accessed May 13, 2026. https://www.ncbi.nlm.nih.gov/books/NBK534778/

3. American Chemical Society. Famotidine. August 3, 2020. Accessed May 13, 2026. https://www.acs.org/molecule-of-the-week/archive/f/famotidine.html

4. Lupin Pharmaceuticals. Lupin Receives U.S. FDA Approval for Glycerol Phenylbutyrate Oral Liquid. May 5, 2026. Accessed May 13, 2026. https://www.prnewswire.com/news-releases/lupin-receives-us-fda-approval-for-glycerol-phenylbutyrate-oral-liquid-302762977.html