Days after Novartis received FDA approval to market Zometa (zoledronic acid for injection) as a hypercalcemia treatment, the drug company filed an additional indication for the drug. Novartis was cleared to market Zometa Aug. 20 for the treatment of hypercalcemia, a potentially deadly release of excess calcium m the blood of cancer patients caused by the breakdown of bone. It has a shorter administration time than the leading treatment, Aredia (pamidronate disoudium for injection), taking only 15 minutes compared with two hours to 24 hours.
Days after the first approval, Novartis submitted an application for Zometa as a treatment for bone complications (metastases) associated with a broad range of tumor types, including prostate, lung, breast and multiple myeloma cancers. Early experience with Zometa in clinical trials treating patients with bone metastases indicated that risk for renal function deterioration (defined as an increase in serum creatinine) is increased in patients who receive the drug over five minutes vs. 15 minutes, so doses of Zometa should not exceed 4 mg and the duration of infusion should be no less than 15 minutes.
COPYRIGHT 2001 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2001 Gale Group
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