Drugs

FDA Denies Tyvaso ANDA Conditions Petition

FDA has denied, without comment on whether it will take the requested action, a United Therapeutics 1/15 petition asking that the agency not approve any ANDA for a treprostinil inhalation solution drug-device combination product referencing Tyvaso unless certain conditions are met. The petition said the ANDA should:

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, with 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.

The agency response says that the answer is being given to meet the 150-day requirement for a petition response. It notes that FDA has made no final determination on whether to approve any ANDA reference Tyvaso as its reference-listed drug. “FDA’s consideration of one or more applications will necessarily inform our decisions on the nature of the data and information necessary to support approval,” it says. “Therefore, we must determine whether it would be appropriate for us to take final agency action on the approvability of a specific aspect of an ANDA before taking final action on the approvability of the ANDA as a whole.

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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