Drugs

Pull Yutrepia Tentative Approval: Petition

United Therapeutics is asking FDA to withdraw its tentative approval of a Liquidia Technologies NDA for Yutrepia (treprostinil) and issue a complete response letter for the application. The 5/10 petition says that LGM Pharma, which United says is Liquidia’s sole active pharmaceutical ingredient (API) supplier, is the subject of an ongoing consent decree in which it admitted liability for committing serious and pervasive violations of the current good manufacturing practice requirements in connection with its handling and processing of APIs for finished drug product manufacturers like Liquidia.

“Unless and until Liquidia successfully completes all steps required by the consent decree or finds a safe alternative to LGM, there can be no assurance that Yutrepia is not tainted,” the petition says.

United Therapeutics asks that FDA:

rescind its award of temporary approval to Liquidia’s Yutrepia NDA;
issue Liquidia a complete response letter for the Yutrepia NDA; and
withhold tentative or final approval of the Yutrepia NDA until LGM has fully and successfully discharged its obligations under the consent decree and Liquidia supplies the agency with sufficient data and information to establish that the identity, strength, quality, and purity of its proposed Yutrepia drug product meets all the statutory and regulatory requirements for approval.

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