TheraRadar
Data updated: May 26, 2026

ARFORMOTEROL TARTRATE

Respiratory Approved 2021-06-22

Arformoterol tartrate helps patients with chronic obstructive pulmonary disease (COPD), including those with chronic bronchitis and emphysema, manage long-term breathing issues. It is used twice daily as a maintenance therapy to address ongoing bronchoconstriction and is administered specifically through a nebulizer. This medication is intended for regular, morning and evening use rather than for treating sudden symptom flare-ups or asthma.

Source: FDA Label • AIPING PHARM INC

How ARFORMOTEROL TARTRATE Works

This drug works by stimulating beta 2-adrenergic receptors, which triggers an increase in intracellular cyclic AMP levels. This chemical change causes the smooth muscles in the bronchi to relax and inhibits the release of hypersensitivity mediators, such as histamine, from mast cells. These combined actions help keep the airways open and reduce the constriction associated with chronic lung disease.

Source: FDA Label
15
Indications
--
Phase 3 Trials
4
Years on Market

ARFORMOTEROL TARTRATE Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
19 FDA actions from 2021 to 2025
Apr 2025 ORIGINAL
Update
Mar 2025 ORIGINAL
Update
Feb 2025 ORIGINAL
Update

What ARFORMOTEROL TARTRATE Treats

4 indications

ARFORMOTEROL TARTRATE is approved for 4 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Chronic Obstructive Pulmonary Disease
  • Chronic Bronchitis
  • Emphysema
  • Bronchoconstriction
Source: FDA Label

ARFORMOTEROL TARTRATE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ARFORMOTEROL TARTRATE

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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT00754546 ARFEET results posted 21261 Ph 4 completed Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD
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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ARFORMOTEROL TARTRATE FDA Label Details

Indications & Usage

ARFORMOTEROL TARTRATE is indicated for the treatment of Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema; Bronchoconstriction.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.