Ritedose Pharmaceuticals has secured U.S. Food and Drug Administration (FDA) approval for generic Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL), addressing a critical nationwide shortage of this essential respiratory medication that has persisted since October 2022.
The newly approved formulation completes Ritedose's comprehensive portfolio of albuterol treatments, which already includes 2.5 mg/3 mL (0.083%), 1.25 mg/3 mL, and 0.63 mg/3 mL strength products. The company expects to make the new dosage available starting in the second quarter of 2025.
"Driven by the needs of escalating health demands in the U.S., Ritedose is strategically expanding its support for critical respiratory therapies," said Jody Chastain, CEO of Ritedose. "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."
Meeting Critical Patient Needs
Albuterol Sulfate Inhalation Solution is primarily used to provide relief of bronchospasms in patients older than 12 years with reversible obstructive airway disease (asthma) and for treating acute attacks of bronchospasm. In the United States alone, more than 26 million people have asthma, with approximately 7 million of them being children.
The medication will be manufactured in Ritedose's expanded, state-of-the-art facilities using advanced Blow-Fill-Seal (BFS) technology, which ensures an automated, safe, and reliable production process. Each single dose will be preservative-free, individually wrapped, and barcoded for safety and tracking.
"Our recent expansion and new packaging line ensures we have the capacity to deliver this medication consistently, efficiently, and safely," Chastain noted. "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."
Expanding Respiratory Medicine Portfolio
Ritedose has established itself as the largest provider of nebulizer products in the United States, having delivered more than 4.5 billion doses throughout the company's history. The approval of the albuterol formulation follows Ritedose's recent FDA approval for formoterol fumarate inhalation solution (20 mcg/2 ml), further solidifying its position in the respiratory medication market.
The company has been strategically expanding its capabilities to address growing demands in respiratory care. Recently, Ritedose added a seventh Syntegon packaging line to enhance its single vial packaging capabilities and expanded its BFS manufacturing operation to add 180 million unit doses of sterile fill-finish capacity in 2024.
Supporting Chronic Respiratory Conditions
Beyond asthma, Ritedose is also addressing needs for patients with Chronic Obstructive Pulmonary Disease (COPD). According to company data, there are 13-15 million COPD patients in the United States, with millions more remaining undiagnosed. COPD represents the sixth-leading cause of death nationally and has an annual economic impact of $50 billion.
Notably, 17% of COPD patients report cost-related non-adherence to medication, highlighting the importance of accessible generic options like those provided by Ritedose.
The company is also the manufacturing partner for Verona Pharma's newly approved COPD drug, Ohutuvayre, demonstrating Ritedose's growing role in supporting breakthrough treatments for respiratory conditions.
About Ritedose
Ritedose is the largest sterile contract development manufacturing organization (CDMO) in the US specializing in sterile Blow-Fill-Seal technology. The Columbia, South Carolina-based company guides the development of molecules from clinical trials to commercialization of branded and generic inhalation and ophthalmic medications.
With its expanding portfolio and manufacturing capabilities, Ritedose continues to position itself as a key provider of essential respiratory medications for hospitals, pharmacies, and patients nationwide.
