Nintedanib · Regulatory approval

FDA approval: Nintedanib

U.S. Food and Drug Administration · April 2, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved an Abbreviated New Drug Application (ANDA) for nintedanib esylate capsules in 100 mg and 150 mg formulations on 2 April 2026, submitted by Dexcel. This is a regulatory action record that does not contain clinical trial results, efficacy data, or comparative evidence; it documents only that the application was approved.

What was studied

Regulatory approval. Intervention: NINTEDANIB ESYLATE CAPSULE, ORAL, 100 mg and 150 mg base.

Key findings

FDA approval granted for NINTEDANIB ESYLATE CAPSULE, ORAL, 100 mg and 150 mg base on 2 April 2026

Safety

This record is an approval action only and does not constitute evidence of efficacy or safety.

Who this may help

This regulatory approval permits marketing of a generic nintedanib formulation. Clinicians should refer to the approved label and existing clinical evidence for nintedanib for information on indications, dosing, and safety.

Plain-language summary

FDA approval of a generic nintedanib formulation; regulatory action without clinical trial data or comparative efficacy claims in this record.

Study design

As stated by the source record.

InterventionNINTEDANIB ESYLATE CAPSULE, ORAL, 100 mg and 150 mg base

Reported figures

Quoted from the source exactly as published.

Approval statusApproved

Approval date2026-04-02

Formulation strengths100 mg and 150 mg

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or comparative benefit evidence.
No information on bioavailability studies, in vitro dissolution, or ANDA-specific evidence is reported in this record.
Approved indications and contraindications are not stated in this regulatory record.
This record is an approval action only and does not constitute evidence of efficacy or safety.

Evidence assessment

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.

Study design

insufficient

Regulatory approval record; no clinical study design reported.

Directness

insufficient

Record does not describe clinical outcomes or direct patient benefit evidence.

Consistency

insufficient

No comparative data or consistency assessment provided in record.

Risk of bias

insufficient

Regulatory approval record; risk of bias assessment not applicable.

Sample adequacy

insufficient

No clinical trial population or sample size reported in this record.

Source abstract

Drugs@FDA record for application ANDA219819. This is a regulatory action record, not a clinical study. Brand name: NINTEDANIB. Active ingredient: NINTEDANIB. Sponsor: DEXCEL. Submission type: ORIG (original application). Approval status date: 2026-04-02. Products: NINTEDANIB ESYLATE, CAPSULE, ORAL, NINTEDANIB ESYLATE EQ 100MG BASE; NINTEDANIB ESYLATE, CAPSULE, ORAL, NINTEDANIB ESYLATE EQ 150MG BASE.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

DexcelNintedanib