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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:  Signifor
Date Designated:  07/24/2009
Orphan Designation:  Treatment of Cushing's disease
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  12/14/2012 
Approved Labeled Indication:  Treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative
Exclusivity End Date:    12/14/2019 
Exclusivity Protected Indication* :  
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.
 
Generic Name:  pasireotide
Trade Name:  Signifor
Date Designated:  07/24/2009
Orphan Designation:  Treatment of Cushing's disease
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  06/29/2018 
Approved Labeled Indication:  SIGNIFOR® LAR is indicated for the treatment of patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.
Exclusivity End Date:    06/29/2025 
Exclusivity Protected Indication* :  Indicated for treatment of patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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