Drugs

Compliance Woes at Wegovy Syringe Plant

A Catalent facility in Brussels, Belgium, that fills syringes for Novo Nordisk’s weight loss drug Wegovy has had FDA compliance issues in recent years affecting product sterility. Reuters reports that it used a Freedom of Information Act request to obtain FDA inspection reports on the Catalent facility.

The news service says there is no evidence that issues at Catalent adversely affected Wegovy users. FDA, it says, issued a final Voluntary Action Indicated determination in 11/2022 that allowed the plant to remain open while it corrected the issues that were identified.

“The most serious findings unearthed by FDA during its 10/2021 visit involved air filtration systems needed to maintain sterile conditions,” Reuters reports. “Inspectors examining historical operational data found the system on one filling line at the plant had failed repeatedly between 2017 and 2021, leading to sterility being ‘compromised’ in the area where drug products were being manufactured, FDA documents say.”

An 8/2022 inspection found new problems with air quality in sterile areas had cropped up since the first visit, Reuters says. “Inspectors on both visits found Catalent staff were not performing required safety controls, with breaches including failing to regularly check that equipment was not contaminated with microbes,” the article reports.

Earlier this week FDA released the form FDA-483 with 12 observations from a 2022 inspection at a Catalent sterile human drug and biologic manufacturing facility in Bloomington, IN.

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