FDA accepts United Therapeutics' resubmitted NDA for Tyvaso DPI as Class 1 review; target date Feb 2022

UNITED THERAPEUTICS Corp

FDA accepted resubmission of NDA for Tyvaso DPI as a Class 1 response after Complete Response Letter in Oct 2021.
User fee goal date (PDUFA) set for February 2022, indicating expedited review.
Tyvaso DPI is an inhaled treprostinil product for pulmonary arterial hypertension.
Resubmission made on Dec 27, 2021, and accepted for review on Jan 18, 2022.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.