Dapagliflozin · Regulatory approval

FDA approval: Dapagliflozin

U.S. Food and Drug Administration · April 6, 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 dapagliflozin formulation (5 mg and 10 mg tablets) manufactured by Ajanta Pharma Ltd on 6 April 2026. This is an ANDA approval, which confirms bioequivalence to a reference product and manufacturing compliance, but does not report the underlying bioequivalence study data or clinical outcomes.

What was studied

Regulatory approval. Intervention: Dapagliflozin 5 mg and 10 mg oral tablets.

Key findings

Dapagliflozin 5 mg and 10 mg tablet formulations approved for oral use Manufacturer: Ajanta Pharma Ltd Approval date: 6 April 2026

Safety

This record does not contain clinical trial results, efficacy data, or comparative safety outcomes. The record does not report adverse events, contraindications, or pharmacokinetic parameters.

Who this may help

This approval permits marketing of a generic alternative to branded dapagliflozin. Clinicians may now prescribe this formulation in place of the originator product; therapeutic equivalence is presumed via FDA's ANDA pathway.

Plain-language summary

FDA approval of a generic dapagliflozin formulation; establishes bioequivalence and manufacturing compliance, not efficacy or clinical superiority.

Study design

As stated by the source record.

InterventionDapagliflozin 5 mg and 10 mg oral tablets

Reported figures

Quoted from the source exactly as published.

Approval status date2026-04-06

Approved strengths5 mg, 10 mg

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or comparative safety outcomes.
Bioequivalence study methodology, sample size, and participant demographics are not disclosed in this approval record.
The record does not report adverse events, contraindications, or pharmacokinetic parameters.
No post-marketing surveillance or real-world outcome data is included.

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 report clinical outcomes or direct efficacy data.

Consistency

insufficient

Single regulatory action; no comparative efficacy or safety data provided.

Risk of bias

insufficient

FDA approval record does not detail bioequivalence study methodology or bias assessment.

Sample adequacy

insufficient

No participant numbers or bioequivalence study details disclosed in this record.

Source abstract

Drugs@FDA record for application ANDA211482. This is a regulatory action record, not a clinical study. Brand name: DAPAGLIFLOZIN. Active ingredient: DAPAGLIFLOZIN. Sponsor: AJANTA PHARMA LTD. Submission type: ORIG (original application). Approval status date: 2026-04-06. Products: DAPAGLIFLOZIN, TABLET, ORAL, DAPAGLIFLOZIN 5MG; DAPAGLIFLOZIN, TABLET, ORAL, DAPAGLIFLOZIN 10MG.

Follow from this

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

DapagliflozinAjanta Pharma