UTHR - United Therapeutics' Challenges FDA Over Liquidia's Drug Approval Process Clocks Strong Q4 Earnings | Benzinga
Wednesday, United Therapeutics Corporation (NASDAQ:UTHR) initiated legal action against the FDA, claiming that the FDA wrongly allowed Liquidia Corporation (NASDAQ:LQDA) to deviate from established rules in the drug approval process.
The litigation focuses on the FDA’s handling of Liquidia’s amendment to a pending new drug application (NDA) related to its proposed inhaled dry powder treprostinil product, seeking to add a second indication for pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Also Read: This United Therapeutics Analyst Is No Longer Bearish, Expects Mid-Decade $4B Revenue Run Rate.
United Therapeutics contends that FDA rules require a new NDA for such a second indication rather than ...