FDA Approves First Generics of Gilotrif (afatinib) Tablets

[7/14/2026] The U.S. Food and Drug Administration approved the first generic versions of GILOTRIF (afatinib tablets) for 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; and treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy.

The prescribing information for generic afatinib tablets includes the same warnings and precautions as GILOTRIF including diarrhea, bullous and exfoliative skin disorders, interstitial lung disease (ILD), hepatic toxicity, gastrointestinal perforation, keratitis, and embryo-fetal toxicity. The most common adverse reactions include diarrhea, rash/acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, and pruritus.

Healthcare providers should review the full prescribing information for complete safety and dosing information. Patient selection for the EGFR mutation-positive indication requires confirmation of non-resistant EGFR mutations in tumor specimens using an FDA-approved test.

Please check FDA’s publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) for a list of approved drug products and contact the manufacturer for information about a medicine’s availability.

For more information about generic drugs, visit Generic Drugs.