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BioPharmaceutical

Novartis Zometa 8 Mg HCM Retreatment Dose Would Need New Study – FDA

This article was originally published in Pharmaceutical Approvals Monthly

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  • Pharmaceutical Approvals Monthly

Executive Summary

Approval of an 8 mg Zometa dose for retreatment of patients with hypercalcemia of malignancy (HCM) would require a new study as well as additional safety data, FDA said in its Aug. 20 approval letter for a 4 mg dose of Novartis’ zoledronic acid
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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