Search Orphan Drug Designations and Approvals
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Generic Name: | eculizumab | ||||||||||||||||
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Trade Name: | Soliris | ||||||||||||||||
Date Designated: | 06/12/2014 | ||||||||||||||||
Orphan Designation: | Treatment of Myasthenia Gravis | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Alexion Pharmaceuticals, Inc. 121 Seaport Boulevard Boston, Massachusetts 02210 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: | eculizumab |
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Trade Name: | Soliris | |
Marketing Approval Date: | 10/23/2017 | |
Approved Labeled Indication: | for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive | |
Exclusivity End Date: | 10/23/2024 | |
Exclusivity Protected Indication* : | for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive | |
2 | Generic Name: | ravulizumab-cwvz |
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Trade Name: | Ultomiris | |
Marketing Approval Date: | 04/27/2022 | |
Approved Labeled Indication: | Treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive | |
Exclusivity End Date: | TBD | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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