Search Orphan Drug Designations and Approvals
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Generic Name: | icatibant | ||||||||||||||||
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Trade Name: | Firazyr | ||||||||||||||||
Date Designated: | 11/25/2003 | ||||||||||||||||
Orphan Designation: | Treatment of angioedema | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Takeda Development Center Americas, Inc. 95 Hayden Avenue Lexington, Massachusetts 02421 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: | icatibant |
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Trade Name: | Firazyr | |
Marketing Approval Date: | 08/25/2011 | |
Approved Labeled Indication: | Treatment of acute attacks of hereditary angioedema in adults 18 years of age and older | |
Exclusivity End Date: | 08/25/2018 | |
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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