UTC’s Suit Against US FDA To Block Application For Tyvaso Rival Invokes Arcane ‘Bundling Rule’

 
• By Brenda Sandburg
  
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United Therapeutics Corp. claims the agency wrongly allowed Liquidia to submit an amendment to add a new indication to its tentatively approved NDA for a rival version of its pulmonary arterial hypertension blockbuster treprostinil.

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US FDA is sued over its acceptance of an amendment to a pending new drug application • Source: Shutterstock

United Therapeutics Corporation contends that the US Food and Drug Administration improperly permitted Liquidia Technologies, Inc. to add a new indication to its pending 505(b)(2) new drug application for Yutrepia (treprostinil) inhalation powder, thereby preventing UTC from obtaining a 30-month stay of approval of the NDA.

Key Takeaways

  • UTC lawsuit says FDA improperly accepted an application supplement for a rival to its Tyvaso that neither allows UTC to bring a patent complaint or contains enough clinical data for the agency to review it.

If approved, the Liquidia product could become a rival to UTC’s Tyvaso, which had US sales of $1.2 billion last...

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