Carboprost Tromethamine · Regulatory approval

FDA approval: Carboprost Tromethamine

U.S. Food and Drug Administration · May 27, 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 carboprost tromethamine 0.25 mg/mL injectable (ANDA 219529) on 27 May 2026 as an original generic application by Somerset Therapeutics LLC. This is a regulatory authorization action that confirms the formulation meets FDA standards for approval but does not report comparative clinical trial data or efficacy outcomes.

What was studied

Regulatory approval.

Key findings

Approval status date: 2026-05-27 Formulation: CARBOPROST TROMETHAMINE 0.25 MG BASE/ML, injectable injection

Safety

This record does not contain clinical trial results, efficacy data, or safety summaries.

Who this may help

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

Plain-language summary

FDA approval of a generic carboprost tromethamine injectable formulation; represents regulatory authorization but does not report clinical trial data or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-27

Formulation strength0.25 mg base/mL

Caveats

This record does not contain clinical trial results, efficacy data, or safety summaries.
No comparative effectiveness or bioavailability data reported.
No indication, dosing regimen, or patient population specified in regulatory record.
Approval status does not imply superiority over or equivalence with other carboprost formulations; bioequivalence standards applied but results not detailed here.

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 record; no clinical study design reported.

Directness

insufficient

No clinical outcome data or patient population described.

Consistency

insufficient

Single regulatory action; no comparative data provided.

Risk of bias

insufficient

Regulatory approval record; clinical trial methodology not reported.

Sample adequacy

insufficient

No sample size or trial population data in regulatory record.

Source abstract

Drugs@FDA record for application ANDA219529. This is a regulatory action record, not a clinical study. Brand name: CARBOPROST TROMETHAMINE. Active ingredient: CARBOPROST TROMETHAMINE. Sponsor: SOMERSET THERAPS LLC. Submission type: ORIG (original application). Approval status date: 2026-05-27. Products: CARBOPROST TROMETHAMINE, INJECTABLE, INJECTION, CARBOPROST TROMETHAMINE EQ 0.25MG BASE/ML.

Follow from this

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

Carboprost TromethamineSomerset Theraps