Venetoclax · Regulatory approval

FDA approval: Venetoclax

U.S. Food and Drug Administration · May 15, 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 a generic venetoclax formulation (10 mg, 50 mg, and 100 mg tablets) by DR REDDY'S under ANDA 214733 on 15 May 2026. This is a regulatory action confirming bioequivalence and manufacturing compliance; it does not report clinical trial results or comparative efficacy data.

What was studied

Regulatory approval. Intervention: Venetoclax 10 mg, 50 mg, and 100 mg oral tablets (generic formulation by DR REDDY'S).

Key findings

FDA approval granted for venetoclax tablets in three strengths: 10 mg, 50 mg, and 100 mg oral formulations

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes. No comparative efficacy or tolerability data versus the reference product are provided.

Who this may help

This approval provides a generic alternative to branded venetoclax, which may improve access and reduce cost for patients receiving venetoclax-containing regimens. Clinical efficacy and safety have already been established for the active ingredient through prior regulatory pathways; this record does not report those data.

Plain-language summary

FDA approval of a generic venetoclax formulation; regulatory action confirming bioequivalence and manufacturing standards, not a clinical efficacy trial.

Study design

As stated by the source record.

InterventionVenetoclax 10 mg, 50 mg, and 100 mg oral tablets (generic formulation by DR REDDY'S)

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-15

Formulations approved10 mg, 50 mg, 100 mg tablets

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
Bioequivalence study design, sample size, and outcomes are not disclosed.
No comparative efficacy or tolerability data versus the reference product are provided.
The record does not specify indications or approved populations for use.

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 trial design reported.

Directness

insufficient

Record does not contain clinical outcome data or trial results.

Consistency

insufficient

No efficacy or comparative data reported in this approval record.

Risk of bias

insufficient

Regulatory action; clinical trial methodology not described.

Sample adequacy

insufficient

Bioequivalence study parameters not disclosed in this record.

Source abstract

Drugs@FDA record for application ANDA214733. This is a regulatory action record, not a clinical study. Brand name: VENETOCLAX. Active ingredient: VENETOCLAX. Sponsor: DR REDDYS. Submission type: ORIG (original application). Approval status date: 2026-05-15. Products: VENETOCLAX, TABLET, ORAL, VENETOCLAX 100MG; VENETOCLAX, TABLET, ORAL, VENETOCLAX 10MG; VENETOCLAX, TABLET, ORAL, VENETOCLAX 50MG.

Follow from this

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

DR ReddysVenetoclax