Posted by Michael Wonder on 27 Feb 2022
Update on Tyvaso DPI new drug application
24 February 2022 - MannKind Corporation was informed that the U.S. FDA issued an information request to United Therapeutics Corporation earlier this month regarding the new drug application for Tyvaso DPI, requesting additional information regarding the pulmonary safety of Tyvaso DPI related to a pending Citizen Petition.
United Therapeutics promptly responded to the agency’s request. MannKind has now learned that the FDA considers the response to be a major amendment to the new drug application, thereby extending to May 2022 the FDA’s deadline to complete its review of the pending new drug application.
