FDA Roundup: December 27, 2024

SILVER SPRING, Md., Dec. 27, 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 announced recommended changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder. The recommended changes intend to encourage the submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs), including to clarify that neither 16 milligrams (mg) per day nor 24 mg/day should be interpreted as maximum dosages for transmucosal buprenorphine products.
  
  
• On Monday, the FDA issued a final rule establishing requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU).
  
  "This action demonstrates the FDA's commitment to improving public health by helping to broaden the types of nonprescription drugs available to consumers," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "The FDA recognizes the benefit of providing consumers with options for additional types of nonprescription drug products, such as some drugs that are currently available only by prescription and that treat certain chronic diseases or conditions."
  
  See the CDER Statement for more information.
  
  
• On Monday, the FDA shared findings from an independent review of publications that document studies on contaminants in tampons. The review is also known as an independent, systematic, literature review. Although limitations were identified in the literature review, as is common, the findings did not identify safety concerns associated with tampon use and contaminant exposure. The FDA continues to recommend FDA-cleared tampons as a safe option for use as a menstrual product. The FDA continues to evaluate the safety and effectiveness of tampons, and an FDA laboratory study of metals in tampon materials is underway. Findings from that study will be shared when they are complete and peer reviewed.
  
  
• On Friday, December 20, the FDA approved Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. Recommended dosing is available in the prescribing information. The most common adverse reactions (reported in at least 5% of patients) to Alhemo were injection site reactions and hives (urticaria). Hypersensitivity reactions including redness of skin (erythema), rash, itching (pruritus), and abdominal pain have occurred in patients treated with Alhemo. Patients with a history of serious hypersensitivity to Alhemo, its components, or its inactive ingredients should not use Alhemo.
  
  
• On Friday, December 20, the FDA's Office of Inspections and Investigations (OII) published a news package featuring the work of its field-based investigators who provide in-person oversight to help keep America's foods safe. In its latest Viewpoint, "During the Holidays and Throughout the Year, Food Safety Is Our Focus", new Deputy Associate Commissioner for Food Products Michael (Mick) Dutcher, DVM, praises his teams' dedication, including their rapid response to recent foodborne outbreaks. In a new WeAreOII staff profile Senior Investigator Megan Rand explains what it's like to be a foods investigator, as well as what motivates her. In the feature, OII Investigators Help Keep Food and Water Safe—at 35,000 Feet, you can learn how investigator Alan Escalona furthers FDA's public health mission, while working from the tarmac and inside an airplane.
  
  
• On Friday, December 20, the FDA approved for marketing Sequana Medical NV's alfapump System, an implanted pump indicated for the removal of excess peritoneal fluid in certain adult patients experiencing fluid buildup in the abdominal cavity due to liver cirrhosis. The alfapump System previously received a Breakthrough Device designation. The alfapump System continuously drains the excess fluid found between the lining of the abdominal wall and the covering of the abdominal organs, also known as the peritoneal cavity, into the bladder where it can exit the body through normal urination. This marketing approval provides patients with a potential alternative to repeat doctor visits for an abdominal tap (paracentesis). The alfapump System is intended for single patient use only.

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.

SOURCE U.S. Food and Drug Administration