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Gilotrif FDA Approval History

FDA Approved: Yes (First approved July 12, 2013)
Brand name: Gilotrif
Generic name: afatinib
Dosage form: Tablets
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer

Gilotrif (afatinib) is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).

Development timeline for Gilotrif

Jan 16, 2018Approval FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC
Apr 15, 2016Approval FDA Approves Gilotrif (afatinib) for Patients with Squamous Cell Carcinoma of the Lung
Jul 12, 2013Approval FDA Approves Gilotrif for Late Stage Non-Small Cell Lung Cancer
Jan 15, 2013U.S. FDA Grants Priority Review to Boehringer Ingelheim's Afatinib NDA for EGFR Mutation-Positive Advanced NSCLC

Further information

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