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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:  08/27/2015
Orphan Designation:  Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  04/25/2017 
Approved Labeled Indication:  Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
Exclusivity End Date:    04/25/2024 
Exclusivity Protected Indication* :  Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant or of had an inadequate response to first-line therapy.
Silvergate Pharmaeuticals, 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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