FDA Roundup: February 16, 2024

SILVER SPRING, Md., Feb. 16, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

On Thursday, the FDA reminded consumers in 5 Medication Safety Tips for Older Adults that even if their medications have worked well for them over the years, they might need to be adjusted or changed later in life. As people age, physical changes can affect the way the body handles medications and how medicines work, which can lead to harmful side effects and drug interactions.

On Thursday, the FDA issued our CDER Drug Safety Priorities l Fiscal Year 2023 report, which highlights key safety-related milestones and accomplishments. The report focuses on programs and initiatives at the core of CDER’s drug safety operations, including the FDA Adverse Event Reporting System and Sentinel System. Read the report for more information on our accomplishments and commitment to public health and drug safety over the past year.

On Thursday, the FDA converted approval of tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations, to traditional approval. Tepotinib was previously granted accelerated approval for this indication on February 3, 2021, based on initial overall response rate (ORR) and duration of response (DOR) in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study. The conversion to traditional approval was based on an additional 161 patients and an added 28 months of follow-up time to assess DOR. View full prescribing information for Tepmetko.

On Thursday, the FDA cleared the PBC Separator with Selux Antimicrobial Susceptibility Testing (AST) System from Selux Diagnostics, Inc. to be marketed in the U.S. The PBC Separator with Selux AST System is an automated lab inoculation preparation system intended for use with positive blood culture samples that can be used for quantitative in vitro antimicrobial susceptibility testing without the traditional overnight subculture. In 2021, the FDA granted Breakthrough Device designation to this system because it represented a breakthrough technology that could help provide more effective treatment for a life-threatening or irreversibly debilitating condition, among other criteria. This marketing clearance reflects the FDA’s ongoing commitment to advance access to safe and effective antimicrobial susceptibility testing intended to aid health care professionals in making more rapid and informed decisions for patients.

On Tuesday, the FDA approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma. View full prescribing information for Onivyde.

Last Thursday, the FDA cleared the eQUANT System from Avails Medical, Inc. to be marketed in the U.S. The eQUANT System is an automated lab inoculation preparation system that consists of a single module instrument which holds a small tube-like container (cuvette) with an electrical sensor. It is intended for use with positive blood cultures samples for direct antimicrobial susceptibility testing without the traditional overnight subculture. The eQUANT System works by preparing samples for direct susceptibility testing by manual agar disk diffusion, a low-cost method used in many clinical microbiology laboratories. This marketing clearance reflects FDA’s ongoing commitment to advance access to safe and effective antimicrobial susceptibility testing intended to aid health care professionals in making more rapid and informed decisions for patients.

This week, the FDA has been updating the announcement of a Listeria monocytogenes outbreak linked to Cotija and Queso Fresco cheeses. FDA has been notified of additional companies who have issued public notifications or recalls for products linked to the Rizo-Lopez Foods, Inc. dairy recall that were sold at retail locations. You can see the entire list of recalled products on the FDA outbreak advisory.

 Additional Resources: 

FDA Newsroom

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Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration