Search Orphan Drug Designations and Approvals
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Generic Name: | glatiramer acetate | ||||||||||||||||
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Trade Name: | Copaxone | ||||||||||||||||
Date Designated: | 11/09/1987 | ||||||||||||||||
Orphan Designation: | Treatment of multiple sclerosis | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Teva Pharmaceuticals USA 1510 Delp Drive Kulpsville, Pennsylvania 19443 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | glatiramer acetate |
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Trade Name: | Copaxone | |
Marketing Approval Date: | 12/20/1996 | |
Approved Labeled Indication: | For reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis. | |
Exclusivity End Date: | 12/20/2003 | |
Exclusivity Protected Indication* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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