FDA Approves Generic Albuterol Sulfate Formulation for Asthma

The FDA has granted approval for Ritedose Pharmaceuticals to manufacture and distribute generic Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL), which is primarily used to relieve bronchospasms in patients older than 12 years with reversible obstructive airway disease, or asthma, and for treating acute attacks of bronchospasm.1

"Driven by the needs of escalating health demands in the U.S., Ritedose is strategically expanding its support for critical respiratory therapies. For the more than 26 million patients suffering from bronchospasms associated with reversible obstructive airway diseases like asthma, this approval brings much-needed access to a critical therapy," Jody Chastain, CEO of Ritedose, said in a statement.1 "Amid a national shortage of this essential drug, we're proud to step-up and help bridge the gap with a full range of albuterol dosages. Patients are at the center of everything we do here at Ritedose."

Ritedose specializes in aseptic unit-dose medication production using Blow-Fill-Seal (BFS) technology, which it says ensures an automated, safe and reliable process. The company, to date, has the largest portfolio of nebulizer products available and has delivered more than 4.5 billion doses over its lifetime. It will manufacture the albuterol doses in the company's expanded, state-of-the-art facilities using BFS technology. Each single dose will be preservative-free, individually wrapped, and barcoded.

Ritedose has previously been granted approval for manufacturing and distributing albuterol 2.5 mg/3 mL (0.083%), 1.25 mg/3 mL, and 0.63 mg/3 mL strength product as well. The new dosage, which is expected to be available starting in the second quarter of 2025, is hoped to help address a nationwide albuterol shortage reported by the FDA since October 2022.

"Our recent expansion and new packaging line ensures we have the capacity to deliver this medication consistently, efficiently, and safely. This milestone reflects the dedication of our hard-working employees, whose commitment is to meet a real and urgent need for patients both in their communities and in communities across the country,” Chastain added.1

In other recent updates for asthma management, new research found that a shared decision-making approach for dialogue with patients with asthma and their caregivers is needed to best address and manage address the nonpharmacologic aspects of asthma management, including social and environmental factors.2

Among recommendations from the Expert Panel Report 3 Guidelines and the United States Environmental Protection Agency (EPA) for managing asthma compiled, clinicians should assess each patient's environmental exposures and tailor mitigation strategies to their specific sensitivities and living conditions. The review found that current guidelines stress that single interventions are often ineffective and a multifaceted approach addressing known triggers, including indoor allergens, tobacco smoke, and air pollutants, is favorable. Additionally, integrated pest management, mold reduction, use of HEPA filters, and smoke-free homes can significantly improve outcomes in sensitized patients.

Clinicians should also advise on reducing exposure to outdoor air pollution, particularly during high-risk events like wildfires or dust storms, and utilizing air purifiers and highly rated filtered ventilation systems.

Clinicians must also proactively consider social determinants of health (SDOH) such as poverty, racism, poor housing, and environmental exposures, all of which drive disparities in asthma prevalence, severity, and outcomes. Clinicians should incorporate validated SDOH screening tools into routine care and ensure resource referrals are available to address unmet social needs, ideally supported by integrated care teams or local networks.

REFERENCES

1. Ritedose Pharmaceuticals Receives FDA Approval for Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL)*--Addressing Nationwide Shortage of the Essential Drug. News release. Ritedose Pharmaceuticals. May 20, 2025. https://www.prnewswire.com/news-releases/ritedose-pharmaceuticals-receives-fda-approval-for-albuterol-sulfate-inhalation-solution-0-5-2-5-mg0-5-mladdressing-nationwide-shortage-of-the-essential-drug-302459668.html

2. Skeen EH, Hamlington KL, De Keyser HH, Liu AH, Szefler SJ. Managing childhood asthma with an eye toward environmental, social, and behavioral features. Ann. Allergy Asthma Immunol. 2025; 134(5): 516-524. DOI: 10.1016/j.anai.2025.02.013