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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Gemtuzumab ozogamicin
Trade Name: Mylotarg
Date Designated: 11/24/1999
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated/Approved
Wyeth Pharmaceuticals, Inc., a Pfizer Company
10646 Science Center Drive
San Diego, California 92121
United States

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

Marketing approved:

1 Generic Name: Gemtuzumab ozogamicin
Trade Name: Mylotarg
Marketing Approval Date: 05/17/2000
Approved Labeled Indication: Treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy
Exclusivity End Date: 05/17/2007 
Exclusivity Protected Indication* :  
2 Generic Name: Gemtuzumab ozogamicin
Trade Name: Mylotarg
Marketing Approval Date: 09/01/2017
Approved Labeled Indication: Treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older
Exclusivity End Date: 09/01/2024 
Exclusivity Protected Indication* :  Treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older
3 Generic Name: Gemtuzumab ozogamicin
Trade Name: Mylotarg
Marketing Approval Date: 06/16/2020
Approved Labeled Indication: Mylotarg¿ is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older.
Exclusivity End Date: 06/16/2027 
Exclusivity Protected Indication* :  For the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in pediatric patients 1 month and older
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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