According to Ritedose Pharmaceuticals, the FDA has approved an ANDA for the company’s generic albuterol sulfate inhalation solution, 0.5%. In April 2023, Ritedose announced that it had begun manufacturing 5 mg/ml albuterol sulfate inhalation solution ampules for sales directly to hospitals under the 503B compounding pharmacy process. The company already marketed 0.021%, 0.042%, and 0.083% albuterol inhalation solution under existing ANDAs.
Ritedose says that it will manufacture the inhalation solution at its recently expanded facility in Columbia, SC, USA and that it expects to have the 0.5% dosage available by mid-2025. The company has also recently announced the addition of an additional blow-fill-and-seal line to support manufacturing of Verona’s Ohtuvayre ensifentrine and FDA approval of the transfer of an ANDA for formoterol fumarate inhalation solution that the company had purchased from another manufacturer.
Ritedose CEO Jody Chastain commented, “Driven by the needs of escalating health demands in the US, 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. 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.”
Read the Ritedose Pharmaceuticals press release.
