United Therapeutics Submits 4th Tyvaso Petition
United Therapeutics has submitted its fourth petition to FDA since 1/14/16 “to ensure that proposed generic treprostinil inhalation solution products meet the same high standards of quality as United Therapeutics’ brand-name product Tyvaso (treprostinil) inhalation solution.” FDA denied the previous three petitions without comment on whether it will take the actions requested by the company. The agency’s most recent denial without comment came 9/5. The latest petition says the company is submitting it to ensure that FDA carefully considers these important issues prior to approving any application submitted under Section 505(j) or 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that references Tyvaso.
According to United’s petition, when a delivery device is approved under an NDA as a component of a drug-device combination product, any ANDA that references the innovator product must also include an equivalent device component. “With respect to a proposed generic delivery system,” it says, “an ANDA applicant must ensure, at a minimum, that its product can be safely and properly administered without the need for retraining by a healthcare professional. Additionally, the proposed generic product’s performance characteristics, operating principles, and critical design attributes must result in a product that will perform the same as the reference-listed drug under the conditions of use described in the labeling.”
Thus, the company says, FDA must refrain from approving an ANDA for a drug-device combination product if the agency determines that (a) the proposed generic device and components differ in critical design attributes; (b) the differences in the generic delivery system would require patients to be retrained in using the device; (c) the generic product includes different conditions of use or otherwise requires labeling changes not permitted under Section 505(j) of the Federal Food, Drug, and Cosmetic Act; or (d) in order to be eligible for approval, the ANDA would need to contain human factor studies or other clinical trial data beyond what is required to show bioequivalence.
“In the present case,” United concludes, “FDA must require that a generic version of Tyvaso include its own delivery system, with the same critical design attributes as Tyvaso, and ensure that it performs the same as the Tyvaso Inhalation System. The resulting generic drug-device combination product must be therapeutically equivalent to Tyvaso. This means that FDA must find that the generic product could be substituted for Tyvaso “with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product.”