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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pasireotide
Trade Name:
Date Designated: 08/25/2009
Orphan Designation: Treatment of acromegaly
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
One Health Plaza
Bldg 104, 3K28
East Hanover, New Jersey 07936
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: pasireotide
Trade Name:
Marketing Approval Date: 12/15/2014
Approved Labeled Indication: Treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option
Exclusivity End Date: 12/15/2021 
Exclusivity Protected Indication* :  Treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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