Drugs

FDA Denies Without Comment UT’s Tyvaso Petition

FDA has denied a United Therapeutics April petition asking that the agency not approve any ANDA referencing Tyvaso (treprostinil) inhalation solution unless the application meets conditions set forth in the petition. The agency denial letter says that because FDA must respond to such petitions within 150 days, it is denying the petition without commenting on whether it will ultimately take the requested action.

United Therapeutics said ANDAs should not be approved for a treprostinil inhalation solution unless they:

request approval for a specific delivery device that will be used with, and approved as part of, the proposed generic treprostinil product;
include data demonstrating that the proposed device component of the generic product has the same critical design attributes and meets the same performance and quality standards as the innovator device, including human factors and usability standards;
include data demonstrating that the proposed generic product and its proposed commercial delivery device is bioequivalent to Tyvaso; and
request approval for a refill kit with the required device components, and include data demonstrating that those components are compatible with both the generic delivery device and the Tyvaso inhalation system, while maintaining the output specifications of the innovator device.

FDA says it has made no final determination on whether to approve any ANDA referencing Tyvaso as its reference-listed drug, and its consideration of one or more applications will necessarily inform its decisions on the nature of the data and information necessary to support approval. It also says there is no evidence that Congress intended to bypass the application review process or to lessen an ANDA applicant’s procedural rights by requiring that FDA make decisions that constitute final agency action regarding the approvability of certain aspects of pending applications on a piecemeal basis outside of the process established in the Federal Food, Drug, and Cosmetic Act and regulations.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome