United Therapeutics files litigation with FDA over rival Liquidia's drug application (updated)

United Therapeutics

21/02/2024 11:51

(Adds details and background throughout)
       Feb 21 (Reuters) - United Therapeutics  UTHR.O  said on
Wednesday it has filed a case with the U.S. FDA, alleging that
due procedure was not followed in allowing rival Liquidia Corp's
 LQDA.O  application for a blood pressure drug.
    United Therapeutics alleged that Liquidia skirted long
standing FDA rules, precedents, and procedures when it filed its
application for an inhaled dry powder of treprostinil, for
pulmonary hypertension associated with interstitial lung disease
(PH-ILD).
    PH-ILD is a group of disorders that cause scarring in the
lungs.
    United Therapeutics has also sued Liquidia for patent
infringement of its drug Tyvaso.
    Liquidia said last month the FDA was still reviewing its
drug, decision on which was due on Jan. 24.
    The FDA and Liquidia did not immediately respond to Reuters
request for a comment.

 (Reporting by Leroy Leo in Bengaluru; Editing by Shinjini
Ganguli)
 ((Leroy.Dsouza@thomsonreuters.com ; https://twitter.com/LeroyLeo7;))