Liquidia Says FDA to Review Amended New Drug Application for Lung Cancer Treatment
By Sabela Ojea
Liquidia says the Food and Drug Administration agreed to review an amendment to its new drug application for Yutrepia to add the treatment of pulmonary hypertension associated with interstitial lung disease to the label.
The biopharmaceutical company on Monday said the FDA set a prescription drug user fee act goal date of Jan. 24, 2024.
If the amendment gets approved by the FDA, Yutrepia would be indicated for the treatment of both pulmonary hypertension and interstitial lung disease and pulmonary arterial hypertension.
The FDA tentatively approved Yutrepia to treat pulmonary arterial hypertension in November 2021.
Write to Sabela Ojea at sabela.ojea@wsj.com
(END) Dow Jones Newswires
September 25, 2023 16:51 ET (20:51 GMT)
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