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Novartis Aredia Follow-On Zometa Priority Goal Date Set For June

Executive Summary

Novartis' bisphosphanate Zometa will receive a priority FDA review for treatment of tumor-induced hypercalcemia. The fast-track review has an estimated user-fee goal date of June 21.

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Novartis Zometa Low, High Doses Have Similar Efficacy - ASCO Study

Novartis' Zometa 4 mg dose showed similar efficacy to the 8 mg dose in a Phase III study comparing zoledronic acid to Novartis' Aredia in the treatment of tumor-induced hypercalcemia, Pierre Major, MD, McMaster University, said May 21 at the American Society of Clinical Oncology annual meeting in New Orleans.

Novartis Zometa Low, High Doses Have Similar Efficacy - ASCO Study

Novartis' Zometa 4 mg dose showed similar efficacy to the 8 mg dose in a Phase III study comparing zoledronic acid to Novartis' Aredia in the treatment of tumor-induced hypercalcemia, Pierre Major, MD, McMaster University, said May 21 at the American Society of Clinical Oncology annual meeting in New Orleans.

Novartis Zometa

Studies are ongoing for bisphosphonate zolendronate in postmenopausal osteoporosis and corticosteroid-induced osteoporosis and are planned in osteogenesis imperfecta, Novartis said. Zometa is receiving FDA fast-track review for tumor-induced hypercalcemia, with a June 21 user-fee goal date (1"The Pink Sheet" Feb. 14, p. 22)

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