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# FDA Again Denies Tyvaso Petition Without Comment
- URL: https://www.fdaweb.com/fda-again-denies-tyvaso-petition-without-comment/
- Published: 2018-02-06T12:00:00.000Z
- Updated: 2026-09-14T23:20:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140690

FDA has denied a fourth petition submitted by United Therapeutics Corp. asking that the agency not approve any ANDA for a treprostinil inhalation solution drug-device combination product referencing its Tyvaso (treprostinil) inhalation solution unless the ANDA meets four requirements specified by the petition. FDA denied the petition without comment on the request for specific requirements because no final decision has yet been made on the approvability of a total ANDA referencing the drug.

The denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-5477-0014&contentType=pdf&ref=fdaweb.com) says the company’s first three petitions were denied 6/13/16, 1/5/17, and 9/1/17, each for the same reason that a final decision had not yet been made on whether to approve such an ANDA.

“We note your current petition makes the same substantive arguments as these earlier petitions,”  
 the letter says.

The petition says that an ANDA referencing Tyvaso should not be approved unless it: 

- requests approval for a specific delivery device that will be used with, and approved as part of, the proposed generic treprostinil product;
- includes data demonstrating that the proposed device component of the generic product has the same critical design attributes and meets the same performance and quality standards as the innovator device, including human factors and usability standards;
- includes data demonstrating that the proposed generic product, with its proposed commercial delivery device, is bioequivalent to Tyvaso; and
- requests approval for a refill kit with the required device components, and includes data demonstrating that those components are compatible with both the generic delivery device and the Tyvaso Inhalation System while maintaining the output specifications of the innovator device.