Search Orphan Drug Designations and Approvals
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Generic Name: | afatinib | ||||||||||||||||
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Trade Name: | Gilotrif | ||||||||||||||||
Date Designated: | 12/03/2012 | ||||||||||||||||
Orphan Designation: | Treatment of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). | ||||||||||||||||
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: | 07/12/2013 | |
Approved Labeled Indication: | First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. | |
Exclusivity End Date: | 07/12/2020 | |
Exclusivity Protected Indication* : | First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. | |
2 | Generic Name: | afatinib |
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Trade Name: | Gilotrif | |
Marketing Approval Date: | 01/12/2018 | |
Approved Labeled Indication: | GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. | |
Exclusivity End Date: | 01/12/2025 | |
Exclusivity Protected Indication* : | GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations other than exon 19 deletions or exon 21 (L858R) substiution mutationas as detected by an FDA-approved test. | |
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