Selenious Acid · Regulatory approval

FDA approval: Selenious Acid

U.S. Food and Drug Administration · June 30, 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 selenious acid intravenous solution (ANDA 219322) on 30 June 2026, manufactured by Zydus Pharmaceuticals, in three formulations (6 mcg/mL, 60 mcg/mL concentrations). This regulatory action authorizes marketing but does not report clinical trial data, efficacy, safety outcomes, or comparative evidence.

What was studied

Regulatory approval. Intervention: Selenious acid intravenous solution, three formulations (6 mcg/mL and 60 mcg/mL concentrations).

Key findings

Approval date: 30 June 2026 Three intravenous formulations approved: 12 mcg selenium/2 mL (6 mcg/mL), 60 mcg selenium/mL, 600 mcg selenium/10 mL (60 mcg/mL) Sponsor: Zydus Pharmaceuticals; submission type: original ANDA

Safety

This regulatory record does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence. No information on indication, dosing recommendations, contraindications, or adverse events is provided in this approval record.

Who this may help

This approval permits Zydus Pharmaceuticals to market selenious acid intravenous solutions; clinicians should consult the product labeling and prescribing information for indications, dosing, contraindications, and safety data. This record alone does not establish clinical efficacy or safety.

Plain-language summary

FDA approval of selenious acid intravenous solution; this is a regulatory action, not a clinical efficacy study, and does not report trial outcomes or comparative benefit.

Study design

As stated by the source record.

InterventionSelenious acid intravenous solution, three formulations (6 mcg/mL and 60 mcg/mL concentrations)

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-30

Formulation 1 concentration12 mcg selenium/2 mL (6 mcg/mL)

Formulation 2 concentration60 mcg selenium/mL

Formulation 3 concentration600 mcg selenium/10 mL (60 mcg/mL)

Clinical bottom line

Caveats

This regulatory record does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.
No information on indication, dosing recommendations, contraindications, or adverse events is provided in this approval record.
ANDA (Abbreviated New Drug Application) format implies a generic or referral product; original efficacy and safety data are not reported here.
Clinical trial design, sample size, endpoints, and statistical results are not included in this regulatory notification.

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 action record; no clinical trial design reported.

Directness

insufficient

Approval record does not report clinical outcomes or direct evidence.

Consistency

insufficient

No comparative data or multiple studies presented in this record.

Risk of bias

insufficient

Regulatory approval record does not assess or report trial bias metrics.

Sample adequacy

insufficient

No sample size or clinical trial population data in approval record.

Source abstract

Drugs@FDA record for application ANDA219322. This is a regulatory action record, not a clinical study. Brand name: SELENIOUS ACID. Active ingredient: SELENIOUS ACID. Sponsor: ZYDUS PHARMS. Submission type: ORIG (original application). Approval status date: 2026-06-30. Products: SELENIOUS ACID, SOLUTION, INTRAVENOUS, SELENIOUS ACID EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML); SELENIOUS ACID, SOLUTION, INTRAVENOUS, SELENIOUS ACID EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML); SELENIOUS ACID, SOLUTION, INTRAVENOUS, SELENIOUS ACID EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML).

Follow from this

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

Zydus PharmsSelenious Acid