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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: neratinib
Date Designated: 08/26/2019
Orphan Designation: Treatment of breast cancer patients with brain metastases
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Puma Biotechnology Inc.
10880 Wilshire Blvd., Suite 2150
Los Angeles, California 90024
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.