FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

CDER Denies Petition on Generic Combination Products

Feb. 8, 2018
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CDER denied a fourth petition from United Therapeutics calling on the center to impose additional conditions before approving generics for combination products that reference its pulmonary arterial hypertension drug Tyvaso unless they meet specific conditions and measure up to the original in terms of performance and bioequivalence.

The applications 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.

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