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# United Therapeutics Submits 5th Tyvaso Petition
- URL: https://www.fdaweb.com/united-therapeutics-submits-5th-tyvaso-petition/
- Published: 2018-02-08T12:00:00.000Z
- Updated: 2026-09-14T23:21:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140716

Five days after FDA [denied](https://www.fdaweb.com/fda-again-denies-tyvaso-petition-without-comment/) without comment United Therapeutics’ fourth Tyvaso (treprostinil) inhalation solution ANDA petition, the company has submitted a fifth [petition](https://www.regulations.gov/document?D=FDA-2018-P-0598-0001&ref=fdaweb.com), that it says is substantively the same as the previous four. In each petition, the company asks that FDA not approve any ANDA for a treprostinil inhalation solution drug-device combination unless the ANDA meets four requirements specified by the company in the petition.

FDA denied the first four petitions without commenting on whether it will take the specific action requested because it says it is required by law to first make a final decision on whether to approve such an ANDA.

United Therapeutics says it submitted the fifth petition “to ensure that FDA carefully considers these important issues prior to approving any application … that references Tyvaso.”