FDA Roundup: March 5, 2024

SILVER SPRING, Md., March 5, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

Today, the FDA announced the availability of a final guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” This guidance is intended to help manufacturers and distributors of new dietary ingredients and dietary supplements prepare and submit new dietary ingredient notifications to the FDA.

Today, the FDA approved the first interchangeable biosimilar to Prolia (denosumab) and Xgeva (denosumab). Jubbonti (denosumab-bbdz) is an interchangeable biosimilar to U.S.-licensed Prolia for the treatment of osteoporosis in certain patient populations, and Wyost (denosumab-bbdz) is an interchangeable biosimilar to U.S.-licensed Xgeva for the treatment of bone complications from cancer.The most common side effects of Jubbonti, like Prolia, were low blood calcium; back, joint, arm, leg and muscle pain;, common cold (runny nose or sore throat), and arthritis.The most common side effects of Wyost, like Xgeva, are tiredness/weakness, low phosphate levels in your blood, diarrhea, nausea, low red blood cells, low blood platelets and calcium levels, back pain, swelling of the lower legs or hands, upper respiratory tract infection, rash, and headache.

Additional information about these medications can be found at the notable approval.

On Monday, the FDA updated its list of select chemicals currently under the agency’s review to provide more insight on the status of the FDA’s post-market assessments of chemicals in the food supply. This updated list includes select food ingredients (including food and color additives), food contact substances, and contaminants under FDA review. The list also includes information about the status of our post-market assessments, including where we are in the risk assessment and management process, as well as our post-market actions. The FDA’s assessment of chemicals in the food supply is part of our commitment to food safety.

On Friday, the FDA approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. The most common adverse reactions (≥20%) were rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea, and vomiting. The FDA also granted traditional approval to amivantamab-vmjw for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The most common adverse reactions (≥ 20%) were rash, IRR, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, and vomiting. The FDA previously granted accelerated approval for this indication. View full prescribing information for Rybrevant.

 Additional Resources: 

FDA Newsroom 

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