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From the Food and Drug Administration
October 3, 2001

Hypercalcemia of Malignancy

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Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2001American Medical Association

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JAMA. 2001;286(13):1569. doi:10.1001/jama.286.13.1569

The FDA has approved zoledronic acid for injection (Zometa; Novartis Pharmaceutical Corp, East Hanover, NJ), an inhibitor of osteoclastic bone resorption, for the treatment of hypercalcemia of malignancy (HCM).

The product was approved on the basis of two identical multicenter, randomized, double-blind, double-dummy trials of Zometa, 4 mg given as a 5-minute intravenous infusion, or pamidronate, 90 mg given as a 2-hour intravenous infusion, in 185 patients with HCM. Patients with recalcitrant or recurrent hypercalcemia received a second dose of Zometa.

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