The FDA denied a United Therapeutics petition urging the agency to reject ANDAs for combination products referencing the company’s hypertension drug Tyvaso (treprostinil).
In its February petition, United Therapeutics asked the FDA not to approve an ANDA for products referencing Tyvaso unless the application specifically requests approval for a delivery device to be used with and approved as part of the proposed generic, unless it demonstrates that the proposed device component has the same critical design attributes and quality standards as the innovator device, and unless it demonstrates bioequivalence to Tyvaso.
The company submitted four similar petitions since 2016 regarding ANDAs that reference Tyvaso, but the agency denied all four on the grounds that it had not made a final decision on any applications that would be affected.
The FDA does not interpret the Food, Drug and Cosmetic Act as “requiring it to render a final decision within the statutory deadline on the approvability of specific aspects of ANDAs before a final decision on the approvability of any such ANDAs,” the agency said.
Read the FDA’s response to the petition here: www.fdanews.com/07-09-18-United.pdf. — Zack Budryk