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# Petition Seeks Restrictions on Tyvasco ANDA Submissions
- URL: https://www.fdaweb.com/petition-seeks-restrictions-on-tyvasco-anda-submissions/
- Published: 2017-04-07T12:00:00.000Z
- Updated: 2026-09-14T22:16:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138401

FDA should refrain from approving a generic copy of United Therapeutic Corp.’s Tyvasco (treprosrinil) if it determines that the proposed generic device and components differ in critical design attributes or if the generic delivery system would require patients to be retrained in use of the device, according to a [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-2162-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) from the innovator company. Tyvasco is a drug-device combination product indicated for treating pulmonary arterial hypertension. The petition also urges FDA to not approve such ANDAs if human factors studies or clinical trial data beyond what is needed to show bioequivalence is required. In those cases, the company says sponsors should be required to submit a 505(b)(2) NDA instead of an ANDA.