United Therapeutics Corporation Receives FDA Acceptance for Tyvaso DPI Review

Strategic Insights -

United Therapeutics Corporation announced on January 18, 2022, that the U.S. Food and Drug Administration (FDA) has accepted its new drug application (NDA) for review as a class 1 response with a user fee goal date in February 2022. This development follows the company's resubmission of the NDA on December 27, 2021, and comes after a Complete Response from the FDA regarding the company's new drug application for Tyvaso DPI on October 18, 2021.

Key Takeaways:

  • United Therapeutics Corporation has received a Complete Response from the FDA concerning its NDA for Tyvaso DPI on October 18, 2021.
  • The company resubmitted the NDA to the FDA on December 27, 2021.
  • The FDA has acknowledged acceptance of the NDA for review as a class 1 response with a user fee goal date in February 2022.
  • Tyvaso DPI is a trademark of United Therapeutics Corporation.
  • The FDA has given the NDA a user fee goal date, indicating a focus on expedited review and approval.

Statistics:

  • October 18, 2021: FDA issued a Complete Response regarding United Therapeutics' NDA for Tyvaso DPI.
  • December 27, 2021: United Therapeutics resubmitted its NDA for Tyvaso DPI to the FDA.
  • January 18, 2022: FDA accepted the NDA for review as a class 1 response with a user fee goal date in February 2022.
  • 1: The FDA has categorized the review of Tyvaso DPI as a class 1 response, indicating a priority focus on expedited review.

Sources:

  • United Therapeutics Corporation, COMTEX, 0000899460, January 18, 2022 (Report date) Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
  • United Therapeutics Corporation, COMTEX, 0000899460, October 18, 2021 (Report date) Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
  • United Therapeutics Corporation, COMTEX, 0000899460, December 27, 2021 (Report date) Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.