Gland Pharma gets U.S. FDA nod for generic Zoledronic Acid injection

Generic injectable and ophthalmic-focused Gland Pharma has received approval from the U.S. Food and Drug Administration for its abbreviated new drug application filed for Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/ mL) Single-Dose Bags.

Bioequivalent and therapeutically equivalent to reference listed drug Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/ mL) of InfoRLife, the product is indicated to treat hypercalcemia of malignancy and multiple myeloma and bone metastases of solid tumours.

The product had U.S. sales of around $6.7 million for the twelve months ending November 2025, Gland Pharma said citing IQVIA numbers.