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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Zoledronate
Trade Name:  Zometa, Zabel
Date Designated:  08/18/2000
Orphan Designation:  Treatment of tumor induced hypercalcemia.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  08/20/2001 
Approved Labeled Indication:  Treatment of hypercalcemia of malignancy.
Exclusivity End Date:   08/20/2008
Exclusivity Protected Indication*:  
Novartis Pharmaceuticals Corp.
59 Route 10
East Hanover, New Jersey 07936

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.