FDA approval: Indocyanine Green

AI Summary

The FDA approved an abbreviated new drug application (ANDA 219139) for Indocyanine Green 25 mg/vial injectable formulation manufactured by Zydus Lifesciences, effective 3 August 2026. This regulatory action confirms bioequivalence and manufacturing compliance with an approved reference product but does not report efficacy, safety, or comparative clinical trial data.

Plain-language summary

This is an FDA approval action for a generic indocyanine green injectable product; it confirms regulatory authorization but does not report clinical trial data or comparative efficacy.

Study design

As stated by the source record.

Reported figures

Quoted from the source exactly as published.

Clinical bottom line

This approval permits marketing of a generic formulation of indocyanine green in the United States. Clinicians should verify that this product is appropriate for their intended use (e.g., vascular imaging, angiography) based on the reference product labeling.

Caveats

• This record does not contain clinical trial results, efficacy data, or safety reports.
• No comparative effectiveness or bioavailability study results are reported in this regulatory record.
• Indication(s) for use, dosing recommendations, and contraindications are not stated in this record.
• The source does not report whether additional postmarketing surveillance or labeling changes have been issued.

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.

Follow from this

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