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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: midostaurin
Trade Name: Rydapt
Date Designated: 07/07/2009
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
One Health Plaza, 105/3W038
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: midostaurin
Trade Name: Rydapt
Marketing Approval Date: 04/28/2017
Approved Labeled Indication: Treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
Exclusivity End Date: 04/28/2024 
Exclusivity Protected Indication* :  Treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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