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Afatinib

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JUL 14, 2026 · REGULATORY APPROVAL

FDA approval: Afatinib

U.S. Food and Drug Administration

FDA approval of a generic afatinib formulation; regulatory action without new clinical trial data or comparative efficacy claims.

Regulatory UpdateAfatinib Hetero Labs LTD V

Reported

Approval date2026-07-14

Application typeANDA (Abbreviated New Drug Application)

Strengths approved20 mg, 30 mg, 40 mg

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