Search Orphan Drug Designations and Approvals
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| Generic Name: | afatinib | ||||||||||||||||
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| Trade Name: | Gilotrif | ||||||||||||||||
| Date Designated: | 08/03/2015 | ||||||||||||||||
| Orphan Designation: | Treatment of non-small cell lung cancer with squamous histology. | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Boehringer Ingelheim Pharmaceuticals, Inc. 900 Ridgebury Road P. O. Box 368 Ridgefield, Connecticut 06877 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: | afatinib |
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| Trade Name: | Gilotrif | |
| Marketing Approval Date: | 04/15/2016 | |
| Approved Labeled Indication: | Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy | |
| Exclusivity End Date: | 04/15/2023 | |
| Exclusivity Protected Indication* : | Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy | |
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