Search Orphan Drug Designations and Approvals
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| Generic Name: | pemigatinib | ||||||||||||||||
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| Trade Name: | Pemazyre | ||||||||||||||||
| Date Designated: | 08/21/2019 | ||||||||||||||||
| Orphan Designation: | Treatment of myeloid/lymphoid neoplasms with eosinophilia and rearrangement of PDGFRA, PDGFRB, or FGFR1, or with PCM1-JAK2 | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Incyte Corporation 1801 Augustine Cut-Off Wilmington, Delaware 19803 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: | pemigatinib |
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| Trade Name: | Pemazyre | |
| Marketing Approval Date: | 08/26/2022 | |
| Approved Labeled Indication: | Treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement | |
| Exclusivity End Date: | 08/26/2029 | |
| Exclusivity Protected Indication* : | Treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement | |
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