Ritedose Pharmaceuticals Secures FDA Approval for 0.5% Albuterol Inhalation Solution

• Ritedose Pharmaceuticals has received FDA approval to manufacture and distribute Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL).

• The new dosage addresses a national shortage and is expected to be available in Q2 2025.

Ritedose Pharmaceuticals, a division of The Ritedose Corporation and the largest sterile CDMO in the US specialising in aseptic unit-dose production using Blow-Fill-Seal (BFS) technology, has received approval from the US Food and Drug Administration (FDA) to manufacture and distribute Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL).

The approval follows growing demand for respiratory treatments in the US and aims to help resolve the national shortage of this essential drug, first reported by the FDA in October 2022. The newly approved dosage complements Ritedose’s existing portfolio, which includes other albuterol strengths such as 2.5 mg/3 mL (0.083%), 1.25 mg/3 mL, and 0.63 mg/3 mL.

Manufacturing will take place at Ritedose’s expanded facilities using its proprietary BFS technology. The company stated that each unit will be preservative-free, individually wrapped, and barcoded for safety. The drug is primarily used for relieving bronchospasms in patients over 12 with reversible obstructive airway disease, including asthma.

“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,” said Jody Chastain, CEO of Ritedose. “Patients are at the centre of everything we do here at Ritedose.”

The new dosage is expected to become available in the second quarter of 2025. The announcement follows Ritedose’s recent investment in packaging capabilities, including the addition of its seventh Syntegon packaging line.