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 $6.7 million for the twelve months ending November 2025.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
