Drug or technology

Nintedanib

3 developments in the corpus

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APR 2, 2026 · REGULATORY APPROVAL

FDA approval: Nintedanib

U.S. Food and Drug Administration

FDA approval of a generic nintedanib formulation; does not contain clinical efficacy data and represents a regulatory action, not evidence of clinical benefit.

Regulatory UpdateNintedanib Apotex

Reported

Approval date2026-04-02

Application typeANDA (Abbreviated New Drug Application)

Formulations approved100 mg and 150 mg nintedanib esylate capsul…

APR 2, 2026 · REGULATORY APPROVAL

FDA approval: Nintedanib

U.S. Food and Drug Administration

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

Regulatory UpdateDexcel Nintedanib

Reported

Approval statusApproved

Approval date2026-04-02

Formulation strengths100 mg and 150 mg

APR 2, 2026 · REGULATORY APPROVAL

FDA approval: Nintedanib

U.S. Food and Drug Administration

FDA approval of a generic nintedanib formulation; establishes regulatory authorization but does not contain clinical efficacy or safety data.

Regulatory UpdateNintedanib DR Reddys

Reported

Approval date2026-04-02

Strengths approved100 mg base, 150 mg base

Dosage formOral capsule