Dexmedetomidine Hydrochloride · Regulatory approval

FDA approval: Dexmedetomidine Hydrochloride

U.S. Food and Drug Administration · April 15, 2026

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AI Summary

This is a regulatory approval action by the FDA for a generic dexmedetomidine hydrochloride injectable formulation (100 mcg/mL, 2 mL vials) via ANDA submission, approved on 15 April 2026. The record documents product authorization but does not contain clinical trial results, efficacy data, or safety comparative evidence.

What was studied

Regulatory approval. Intervention: Dexmedetomidine hydrochloride injectable formulation, 100 mcg/mL, 2 mL vials.

Key findings

Dexmedetomidine hydrochloride injectable (100 mcg/mL concentration) approved by FDA via ANDA application ANDA208103 Approval date: 15 April 2026 Sponsor: Baxter Healthcare Corp

Safety

This is a regulatory approval document; it does not report clinical trial results, efficacy endpoints, or comparative safety data. No clinical evidence, patient outcomes, or pharmacokinetic/pharmacodynamic data are provided in this record.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA approval of dexmedetomidine hydrochloride generic injectable formulation; regulatory action establishing product availability but does not report clinical trial efficacy or safety data.

Study design

As stated by the source record.

InterventionDexmedetomidine hydrochloride injectable formulation, 100 mcg/mL, 2 mL vials

Reported figures

Quoted from the source exactly as published.

Approved concentration100 mcg/mL

Approved vial size2 mL

Application typeANDA (Abbreviated New Drug Application)

Caveats

This is a regulatory approval document; it does not report clinical trial results, efficacy endpoints, or comparative safety data.
No clinical evidence, patient outcomes, or pharmacokinetic/pharmacodynamic data are provided in this record.
No information on indication, dosing guidance, contraindications, or adverse event profile is included in the approval notice itself.

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 study design reported.

Directness

insufficient

Approval record does not report clinical endpoints or direct efficacy evidence.

Consistency

insufficient

Single regulatory action; no comparative clinical data or consistency analysis provided.

Risk of bias

insufficient

Regulatory approval document; no trial methodology or bias assessment reported.

Sample adequacy

insufficient

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

Source abstract

Drugs@FDA record for application ANDA208103. This is a regulatory action record, not a clinical study. Brand name: DEXMEDETOMIDINE HYDROCHLORIDE. Active ingredient: DEXMEDETOMIDINE HYDROCHLORIDE. Sponsor: BAXTER HLTHCARE CORP. Submission type: ORIG (original application). Approval status date: 2026-04-15. Products: DEXMEDETOMIDINE HYDROCHLORIDE, INJECTABLE, INJECTION, DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML).

Follow from this

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

Dexmedetomidine HydrochlorideBaxter Hlthcare