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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: N-(4,4-difluorocyclohexyl)-2-(3-methyl-1H-pyrazol-1-yl)-6-morpholinopyrimidin-4-amine
Date Designated: 05/22/2019
Orphan Designation: Treatment of spinocerebellar ataxia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Novartis Pharmaceuticals Corporation
One Health Plaza
Building 337/03/A13L1-22
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.