TheraRadar
Data updated: Jun 28, 2026

BROVANA (arformoterol tartrate) · Lupin

Respiratory Approved 2006-10-06

BROVANA is FDA-approved to treat 4 conditions (same as ARFORMOTEROL TARTRATE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
19
Years on Market

Details

Status
Discontinued
First Approved
2006-10-06
Routes
INHALATION
Dosage Forms
SOLUTION

Companies

Lupin
Active Ingredient: ARFORMOTEROL TARTRATE

BROVANA Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
20 FDA actions from 2006 to 2019 · 1 indication expansions
May 2019 SUPPL
Label · Labeling
FDA Letter Label
Dec 2016 SUPPL
Mfg · Manufacturing (CMC)
Jul 2016 SUPPL
Mfg · Manufacturing (CMC)

What BROVANA Treats

4 indications

BROVANA is approved for 4 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as ARFORMOTEROL TARTRATE (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT03219866 results posted IRB00042362 Ph 4 terminated Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD)
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

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

BROVANA FDA Label Details

Indications & Usage

FDA Label (PDF)

BROVANA is FDA-approved to treat 4 conditions — same approved indications as ARFORMOTEROL TARTRATE.

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Data Sources

FDA Approval: NDA021912 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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