USFDA6 Feb 2026, 11:15 am
Gland Pharma Receives USFDA Approval for Zoledronic Acid Injection
AI Summary
Gland Pharma Limited has received approval from the USFDA 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, 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. The product had US sales of approximately USD 6.7 million for the twelve months ending November 2025.
Key Highlights
- Gland Pharma receives USFDA approval 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, 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 Tumors
- The product had US sales of approximately USD 6.7 million for the twelve months ending November 2025
- Gland Pharma is a leading injectable-focused company with a global footprint across 60 countries