Ritedose Pharmaceuticals has announced that the FDA approved the transfer of an ANDA for formoterol fumarate inhalation solution to Ritedose in April 2025. The company says that it expects to start shipping formoterol fumarate inhalation solution by mid-2025.
In the announcement, Ritedose notes that it purchased the ANDA in 2024 from another manufacturer. According to the FDA drug database, ANDA #216486, which is currently assigned to Ritedose, was originally approved on November 25, 2022. Aucta Pharma announced on December 1, 2022 that the agency had approved its ANDA for a generic of Perforomist formoterol fumarate inhalation solution.
Ritedose, which manufactures inhalation solutions including albuterol sulfate, ipatropium bromide, arformoterol tartrate, and cromolyn sodium, announced an expansion of its blow-fill-seal capacity in June 2024. The company also provides contract manufacturing services for products such as Verona Pharma’s Ohtuvayre ensifentrine.
Ritedose President and CEO Jody Chastain commented, “Expanding our generics portfolio is one more way we’re working to meet the real, ongoing needs of patients and our partners. It’s estimated that between 13 and 15 million people have a clinical need for this drug. With a strong pipeline in development and several product launches on the horizon, we’re committed to being a dependable generics manufacturer.”
Read the Ritedose Pharmaceuticals press release
