Lupin’s U.S. Win: Famotidine Injection Gets FDA Nod

The approval covers Famotidine Injection, 10 mg/mL (20 mg/2 mL) single‑dose vials and allows Lupin to market a generic alternative to Merck’s Pepcid® Injection in the U.S. hospital and acute‑care setting. Lupin announced the FDA action via a PR notice dated May 13, 2026.

Product And Indication

Famotidine Injection is indicated for intravenous use in patients requiring parenteral therapy for acid‑related disorders when oral administration is not feasible, including active duodenal ulcer, benign gastric ulcer, GERD and pathological hypersecretory conditions such as Zollinger‑Ellison syndrome. Lupin states the product is bioequivalent to the reference listed drug.

Manufacturing And Commercial Details

Lupin said the drug will be produced at its Nagpur manufacturing site in India, which supplies several of the company’s injectable generics for global markets. The approval strengthens Lupin’s sterile injectables pipeline for the U.S., complementing recent tentative approvals and ANDA clearances the company has secured.

Key Highlights

• U.S. FDA has approved Lupin’s ANDA for Famotidine Injection USP, 20 mg/2 mL single‑dose vials.
• The product is AB‑rated as bioequivalent to Pepcid® Injection (Merck).
• Indications include IV treatment for ulcers, GERD and pathological hypersecretory conditions.
• Manufacturing will be at Lupin’s Nagpur injectable facility in India.
• The approval adds to Lupin’s growing U.S. sterile injectables portfolio following recent tentative ANDA clearances.

Why It Matters

For Lupin, the approval opens an addressable market in U.S. hospitals for an established acid‑suppression injectable, potentially supporting sales and margin improvement in the regulated U.S. generics market. For hospitals and health systems, a new generic supplier can help with supply continuity and competitive pricing versus the branded RLD.

Sources: Lupin press release/PR Newswire, MarketScreener summary of the FDA approval