United Therapeutics Petitions FDA Not to Approve Tryvaso Generics With Major Design Changes

September 12, 2017

United Therapeutics called on the FDA not to approve ANDAs for generic combination products referencing Tryvaso unless they meet four conditions.

United submitted the request in a citizen petition. The company asked the agency to withhold approval for any combination products referencing their product that does not:

  • Include a request for approval for a specific delivery device that will be used with the proposed generic;
  • Include data demonstrating the proposed device component measures up to the original in terms of design attributes, performance and quality standards, and human factors and usability standards;
  • Provide data demonstrating the proposed product’s bioequivalence; and
  • Request approval for refill kits with the required device components and document those components’ compatibility with both the Tyvaso system and the generic delivery system.

In addition, the company asked the FDA not to approve proposed generics that would require retraining patients in their use, or that would require data from human factors studies or clinical trials beyond what is necessary to demonstrate bioequivalence.

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