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Afatinib · Regulatory approval
U.S. Food and Drug Administration · July 14, 2026
An action by a regulator. Authoritative on labelling and availability.
The FDA approved a generic afatinib dimaleate formulation (20 mg, 30 mg, and 40 mg tablets) manufactured by Hetero Labs Ltd on 14 July 2026. This is a regulatory action documenting approval of the product and does not report clinical trial results, comparative efficacy, or safety data.
Regulatory approval.
FDA approved AFATINIB DIMALEATE tablets in three strengths: 20 mg, 30 mg, and 40 mg base equivalent
This record does not contain clinical trial data, efficacy outcomes, or safety results. No information on bioavailability, pharmacokinetic studies, or manufacturing details is provided in this record.
The source did not state who this applies to in practice.
FDA approval of a generic afatinib formulation; regulatory action without new clinical trial data or comparative efficacy claims.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Drugs@FDA record for application ANDA210750. This is a regulatory action record, not a clinical study. Brand name: AFATINIB. Active ingredient: AFATINIB. Sponsor: HETERO LABS LTD V. Submission type: ORIG (original application). Approval status date: 2026-07-14. Products: AFATINIB DIMALEATE, TABLET, ORAL, AFATINIB DIMALEATE EQ 30MG BASE; AFATINIB DIMALEATE, TABLET, ORAL, AFATINIB DIMALEATE EQ 40MG BASE; AFATINIB DIMALEATE, TABLET, ORAL, AFATINIB DIMALEATE EQ 20MG BASE.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.