Gland Pharma receives USFDA approval for Zoledronic Acid Injection

Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application filed for Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/ mL) Single-Dose Bags.

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/ mL) of InfoRLife.

This Product is indicated to treat Hypercalcemia of Malignancy and Multiple Myeloma and Bone Metastases of Solid Tumors.

According to IQVIA, the product had US sales of approximately USD 6.7 million for the twelve months ending November 2025.

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