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Nintedanib Esylate · Regulatory approval
U.S. Food and Drug Administration · August 3, 2026
An action by a regulator. Authoritative on labelling and availability.
The FDA approved a generic nintedanib esylate formulation (100 mg and 150 mg capsules) from MacLeods Pharmaceuticals on 3 August 2026 via an abbreviated new drug application (ANDA). This approval action establishes regulatory compliance and presumed bioequivalence to the reference product but does not contain clinical efficacy data or comparative trial results.
Regulatory approval. Intervention: Nintedanib esylate, capsule, oral, 100 mg and 150 mg base equivalent.
FDA approval granted for nintedanib esylate 100 mg and 150 mg oral capsules Approval date: 3 August 2026 Sponsor: MacLeods Pharmaceuticals
This regulatory record does not contain clinical trial results, efficacy data, or safety outcomes. No comparative clinical data are reported; approval is based on pharmaceutical equivalence and presumed bioequivalence.
This is a generic approval, not a clinical efficacy study. Clinicians should understand that the approved formulation meets FDA bioequivalence standards and is therapeutically equivalent to the reference product. The record does not provide clinical trial results or comparative outcome data.
FDA approval of a generic nintedanib esylate formulation; establishes bioequivalence and manufacturing compliance but does not report clinical efficacy or comparative trial data.
As stated by the source record.
Quoted from the source exactly as published.
This is a generic approval, not a clinical efficacy study. Clinicians should understand that the approved formulation meets FDA bioequivalence standards and is therapeutically equivalent to the reference product. The record does not provide clinical trial results or comparative outcome data.
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 ANDA219926. This is a regulatory action record, not a clinical study. Brand name: NINTEDANIB ESYLATE. Active ingredient: NINTEDANIB ESYLATE. Sponsor: MACLEODS PHARMS. Submission type: ORIG (original application). Approval status date: 2026-08-03. Products: NINTEDANIB ESYLATE, CAPSULE, ORAL, NINTEDANIB ESYLATE EQ 150MG BASE; NINTEDANIB ESYLATE, CAPSULE, ORAL, NINTEDANIB ESYLATE EQ 100MG BASE.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.