Novartis Zometa

Serum creatinine data from Novartis' ongoing zolendronate trials for the treatment of bone metastases is among FDA's requests in a Sept. 21 "approvable" letter for Zometa in hypercalcemia of malignancy. In June, Novartis eliminated the 8 mg arm of the ongoing studies after elevated serum creatinine levels were detected in some patients (1"The Pink Sheet" June 26, p. 21). A priority review user fee goal date of June 21 was extended three months at that time. The bone metastases studies are scheduled to be complete within the first half of 2001