Drugs

United Therapeutics Sues FDA Over Liquidia NDA

United Therapeutics says it is suing FDA over the agency’s decision to permit Liquidia Corp. to add a second proposed indication to its NDA for Yutrepia (treprostinil) inhalation powder. In a statement, United says FDA mistakenly permitted Liquidia to amend its NDA and “skirt longstanding FDA rules, precedents, and procedures on how pending drug approval applications are handled by the agency. In doing so, FDA inappropriately denied United Therapeutics its right to obtain a stay of Liquidia’s final approval until United Therapeutics’ pending patent infringement claim against Liquidia can be resolved.”

United says that under FDA rules, precedents, and procedures, Liquidia should have had to seek an indication for pulmonary hypertension associated with interstitial lung disease (PH-ILP) by filing a new NDA rather than filing an amendment to its pending NDA. “United Therapeutics believes this distinction is critical to ensure the proper review and approval of new drug applications in a fair, equitable manner consistent with FDA’s prior practices with which industry has complied for decades,” the company says.

On 1/25, FDA informed Liquidia that it would miss the 1/24 PDUFA action date for the amended Yutrepia NDA because the agency is confirming the process for adding the PH-ILP indication as an NDA amendment.

FDA issued an 11/5/2021 tentative approval for Yutrepia to treat pulmonary arterial hypertension to improve exercise ability in specified adults. Liquidia filed its amendment in 7/2023 seeking to add PH-ILP to the label indication. “FDA previously confirmed that Yutrepia may include the treatment of PH-ILD to the proposed label for Yutrepia without additional clinical studies,” Liquidia said.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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