CDER Denies Fourth United Therapeutics Petition on ANDAs Referencing Tyvaso

CDER denied a fourth petition from United Therapeutics calling on the center to impose additional conditions before approving ANDAs for combination products that reference its pulmonary arterial hypertension drug Tyvaso unless they meet specific conditions and measured up to the original in terms of performance and bioequivalence.

The ANDAs should request approval for a specific device and for refill kits with the required device components and document their compatibility with both the generic and Tyvaso delivery systems, the company said.

United had submitted three similar petitions, two in 2016 and one last April, all of which were denied without further comment as the FDA had not made a final decision on how to proceed with such applications. The agency still has not made a decision on whether or not to approve ANDAs referencing Tyvaso.