zoledronic acid Injection Ready-to-Use Solution for Intravenous Infusion
(For Single Use) Concentrate for Intravenous Infusion Initial U.S. Approval: 2001
zoledronic acid Injection is a bisphosphonate indicated for the treatment of: • Hypercalcemia of malignancy. • Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Important limitation of use: The safety and efficacy of Zometa has not been established for use in hyperparathyroidism or nontumor-related hypercalcemia.
Facts about zoledronic acid Injection
Approval Date: 2001
Proprietary Name: On Request
Active Ingredient(s): zoledronic acid Injection
Dosage Forms And Strengths: 4 mg/100 mL single-use ready-to-use bottle (3) 4 mg/5 mL single-use vial of concentrate
Manufacturer: Novartis Pharmaceuticals Corporation
Medicine Approved By: – European Medical Agency (EMA), Food and Drug Administration (FDA), Health Canada, Therapeutic Goods Administration (TGA), Medsafe (NZ)
Summary of FDA approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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