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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
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.

Marketing approved:

1 Generic Name: methotrexate oral solution
Trade Name: Xatmep
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.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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