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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  methotrexate oral solution
Trade Name:  Xatmep
Date Designated:  05/28/2015
Orphan Designation:  Treatment of acute lymphoblastic leukemia in pediatric patients (0 through 16 years of age)
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  04/25/2017 
Approved Labeled Indication:  Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen
Exclusivity End Date:    04/25/2024 
Exclusivity Protected Indication* :  Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen
Silvergate Pharmaceuticals, Inc.
6251 Greenwood Plaza Blvd.
Suite 101
Greenwood Village, Colorado 80111
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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