Prescription medicine
Arformoterol First approved as Brovana
Arformoterol (Brovana) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 15 generic labelers, and pharmacies paid $0.633 per mL (Arformoterol 15 mcg/2 mL solution) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the arformoterol FDA label on DailyMed (effective April 14, 2026, Sun Pharmaceutical Industries, Inc.); the NDA 21912 record on Drugs@FDA; every arformoterol label on DailyMed.
Highlights of the record
FDA label of April 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageArformoterol tartrate inhalation solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Forms and strengths
- 2ml
Solution.
On the market
- Earliest approval on file
- October 6, 2006 Brovana, Lupin; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 17 first June 22, 2021; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 15 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.633 per mL Arformoterol 15 mcg/2 mL solution
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2021 0 Class I among all firms' recalls; latest September 29, 2022
- FAERS reports
- 231 through July 30, 2026
What is arformoterol used for?
From the label: indications and usageArformoterol tartrate inhalation solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1) Important limitations of use: Arformoterol tartrate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. (1.2, 5.2) Arformoterol tartrate inhalation solution is not indicated to treat asthma. […]
Conditions named in the indications of arformoterol's FDA labels, with every medicine labeled for each:
From other arformoterol labelsCOPD: Treatment of COPD Arformoterol tartrate inhalation solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) …
FDA pharmacologic class: beta2-Adrenergic Agonist.
Source: FDA drug label (Arformoterol Tartrate), Sun Pharmaceutical Industries, Inc., effective April 14, 2026 (SPL set f1005878-0c48-4b9a-843e-b6cf6b8bb251), via openFDA; the full label on DailyMed
Is there a generic for arformoterol (Brovana)?
The FDA approved the first generic arformoterol on June 22, 2021. 17 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists arformoterol from 15 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2006 earliest approval on file
- 2021 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for arformoterol (Brovana)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.633 per mL (Arformoterol 15 mcg/2 mL solution), down 10% from $0.699 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Arformoterol 15 mcg/2 mL solution (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Arformoterol 15 mcg/2 mL solution | Generic | $0.633 per mL | n/a | -10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has arformoterol been recalled?
The FDA's Enforcement Report lists 2 recalls naming arformoterol since 2021: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 29, 2022 | Class II | CIPLA | Lack of Assurance of Sterility: environmental monitoring failure. |
| August 27, 2021 | Class II | Glenmark Pharmaceuticals Inc., USA | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the arformoterol label say about other medicines?
The arformoterol label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name arformoterol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Albuterol | warnings and precautions | Doses of the related beta 2 -agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. |
| Aminophylline | drug interactions | Steroids or Diuretics Concomitant treatment with methylxanthine (aminophylline, theophylline), steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists including arformoterol tartrate inhalation solution [see Warnings and Precautions (5.7)]. |
| Formoterol | contraindications | CONTRAINDICATIONS Arformoterol tartrate inhalation solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. |
| Salmeterol | warnings and precautions | A 28-week, placebo-controlled US study comparing the safety of another LABA (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs. 3/13,179 in patients treated with placebo; |
| Theophylline | drug interactions | Steroids or Diuretics Concomitant treatment with methylxanthine (aminophylline, theophylline), steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists including arformoterol tartrate inhalation solution [see Warnings and Precautions (5.7)]. |
Other labels that name arformoterol
Source: FDA drug label (Arformoterol Tartrate), Sun Pharmaceutical Industries, Inc., effective April 14, 2026 (SPL set f1005878-0c48-4b9a-843e-b6cf6b8bb251), via openFDA; the full label on DailyMed
What do FAERS reports show for arformoterol?
The FDA Adverse Event Reporting System holds 231 reports that list arformoterol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13 are coded as a death and 79 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as arformoterol?
17 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as arformoterol or labeled mainly for the same use (COPD), the same class first. COPD lists all 23 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (respiratory (inhalation)) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fluticasone and salmeterol | COPD | 8 labelers | $1.07 per unit 100-50 | A presentation being discontinued |
| Albuterol and ipratropium | COPD | 14 labelers | $0.0787 per mL 0.5-3(2.5) mg/3 mL | No current entry |
| Budesonide and formoterol | COPD | 2 labelers | $17.26 per gram 160-4.5 | No current entry |
| Formoterol | COPD | 11 labelers | $1.30 per mL 20 mcg/2 mL neb vial | No current entry |
| Fluticasone and vilanterol | COPD | none listed | $3.90 per unit 100-25 | No current entry |
| Budesonide and formoterol and glycopyrrolate | COPD | none listed | $61.41 per gram 160-9-4.8 mcg | No current entry |
| Fluticasone and umeclidinium and vilanterol | COPD | none listed | $11.12 per unit 100-62.5-25 | No current entry |
| Umeclidinium and vilanterol | COPD | none listed | $4.95 per inhaler 62.5-25 mcg inhaler | No current entry |
Every medicine labeled for the same conditions as arformoterol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does arformoterol compare with medicines for the same use?
1 side-by-side page set arformoterol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to arformoterol
- 17 medicines for the same use
- Other beta-2 agonists
- the pharmacologic class, with prices and generics
- Arformoterol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other