FDA Approves Amneal’s Albuterol Sulfate Inhalation Aerosol

The FDA has approved albuterol sulfate inhalation aerosol (Amneal) marking a major milestone for the company’s growing respiratory portfolio and potentially expanding access to an essential rescue medication for millions of Americans with asthma and chronic obstructive pulmonary disease (COPD).¹ This approval adds a therapeutically equivalent generic version of albuterol sulfate, 90 mcg per actuation, to the US market at a time when availability, affordability, and supply of inhaled respiratory medications remain a national concern.

Albuterol is a short-acting β₂-adrenergic agonist (SABA) that is commonly used to quickly relieve bronchospasm. Its availability is important to both children and adults who use rescue inhalers to control their symptoms.

According to CDC data, over 25 million people have asthma in the US, and about 16 million people have COPD. SABAs are still the mainstay of therapy for acute symptom relief of both conditions.² The FDA’s decision paves the way for additional generic alternatives in the respiratory space, which has historically been limited due to the complexity of developing inhalation products.

Clinical Development and FDA Review

The approval relied on data from a randomized, double-blind, single-dose, 2-way crossover, phase 1 clinical trial (NCT03549897) that compared the pharmacokinetics, safety, and equivalence of albuterol sulfate (PROAIR HFA; Teva).³ The study included healthy adult participants and evaluated maximum observed plasma concentration (Cmax) and area under the concentration-time curve AUC as the primary endpoints. The results met the FDA's standards for bioequivalence, indicating that the systemic exposure levels of the 2 products were similar.³

Albuterol sulfate inhalation aerosols are considered combination products and therefore demand an intensive evaluation of the drug formulation, device performance, aerodynamic particle size distribution, dose uniformity, and patient usability. Due to the complexity of these approvals, there have been only a few manufacturers that have been able to enter this space, often resulting in higher prices and shortage of products. The successful approval of this new generic underscore both the scientific and engineering challenges involved in inhalation product development.

Strengthening a Growing Respiratory Portfolio

This marks Amneal’s consecutive major respiratory approval after the beclomethasone dipropionate inhalation aerosol (Qvar RediHaler; Amneal), received FDA approval in November 2025.¹ Together, these wins represent significant progress in the company’s long-term strategy to expand its inhalation-based therapeutics and establish a competitive presence across both maintenance and rescue respiratory therapies.

“Securing two significant inhalation approvals this quarter—first beclomethasone dipropionate and now albuterol—highlights the tremendous progress our teams have made in a highly complex respiratory category,” said Srinivas Kone, PhD, Senior Vice President, Chief Scientific Officer – Affordable Medicines. “These achievements are the result of years of hard work, engineering excellence, and investment in our respiratory platform, and they position Amneal to deliver meaningful growth and patient impact.”¹

Impact on Patient Care

Albuterol remains the most commonly prescribed rescue therapy for patients experiencing acute bronchospasm. Increased market competition—especially in the case of inhalers—has proven to be beneficial in lowering prices, improving supply consistency, and increasing patient access to necessary medicines. As per the data from several national surveys, many patients with asthma and COPD refrain from taking their medication due to its cost, and the availability of generics contributes greatly to making the treatment more affordable.²

With the FDA’s latest approval, Amneal is positioned to contribute meaningfully to this access gap. The company expects the product to launch in the coming months, adding another FDA-approved, therapeutically equivalent option for clinicians and patients nationwide.

REFERENCES

1. Amneal receives U.S. FDA approval for albuterol sulfate inhalation aerosol. GlobeNewswire. Published December 2, 2025. Accessed December 2025. https://www.globenewswire.com/news-release/2025/12/02/3197859/0/en/Amneal-Receives-U-S-FDA-Approval-for-Albuterol-Sulfate-Inhalation-Aerosol.html

2. Centers for Disease Control and Prevention. Asthma data, statistics, and surveillance. Accessed December 2025. https://www.cdc.gov/asthma

3. ClinicalTrials.gov. Pharmacokinetics study of albuterol sulfate HFA inhalation aerosol (NCT03549897). https://clinicaltrials.gov/study/NCT03549897