Gland Pharma has secured USFDA approval for its Abbreviated New Drug Application (ANDA) for Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/mL) Single-Dose Bags. This approval allows Gland Pharma to market a generic version of Zoledronic Acid, used to treat hypercalcemia of malignancy, multiple myeloma, and bone metastases from solid tumors. The reference drug is Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/mL), from InfoRLife. The announcement was made on February 6, 2026.
USFDA Approval Granted
Gland Pharma Limited announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/mL) Single-Dose Bags on February 6, 2026.
Therapeutic Equivalence
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Zoledronic Acid Injection, 4 mg/100 mL (0.04 mg/mL), marketed by InfoRLife.
Indications
This product is indicated for the treatment of Hypercalcemia of Malignancy, Multiple Myeloma, and Bone Metastases of Solid Tumors.
Market Data
According to IQVIA data, the US market sales for Zoledronic Acid Injection were approximately USD 6.7 million for the twelve months ending November 2025.
Source: BSE
