Posted by Michael Wonder on 24 Feb 2022
United Therapeutics Corporation reports fourth quarter and full year 2021 financial results
24 February 2022 - Major amendment to Tyvaso DPI new drug application pushes FDA decision date to May 2022.
United Therapeutics recently received an information request letter from the U.S. FDA requesting additional information regarding the pulmonary safety of Tyvaso DPI related to a pending Citizen's Petition.
United Therapeutics responded to the agency’s information request; however, the FDA has considered this response to be a major amendment to the new drug application, extending FDA’s review deadline to May 2022.
