SA国际传媒

American Society of Addiciton Medicine
Jan 9, 2025 Reporting from Rockville, MD
SA国际传媒Applauds FDA Clarification for Buprenorphine Labeling
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Jan 9, 2025

SA国际传媒Applauds FDA Clarification for Buprenorphine Labeling.Substring(0, maxlength)

American Society of Addictin Medicine

News

SA国际传媒Applauds FDA Clarification for Buprenorphine Labeling

FDA encourages manufacturers of buprenorphine-containing transmucosal products for the treatment of opioid use disorder to revise labeling to clarify that there is no specified maximum dose  

Rockville, MD (Jan. 9, 2025) – In response to the Food and Drug Administration’s (FDA) Federal Register notice, , and its subsequent , Brian Hurley, MD, MBA, FAPA, DFASAM, president of the SA国际传媒 (ASAM), issued the following statement: 

“SA国际传媒is encouraged by the FDA’s recommendation that products containing transmucosal buprenorphine for the treatment of opioid use disorder (OUD) should have their labels revised to clarify that there is no maximum dose.  

Given the prevalence of high-potency synthetic opioids, treating patients with an effective, appropriate dose of buprenorphine is critical to get them on the path to remission and recovery. The misconception that there is a maximum dose in the labeling is harmful to patients. It can ultimately delay or prevent potentially lifesaving care; we have also seen this limit Medicaid and private insurance coverage for clinically appropriate, higher doses of buprenorphine. 

Further, this important clarification is in alignment with .” 

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About the SA国际传媒    

The SA国际传媒 (ASAM), founded in 1954, is a professional medical society representing over 7,000 physicians, clinicians, and associated professionals in the field of addiction medicine. SA国际传媒is dedicated to increasing access and improving the quality of addiction treatment, educating physicians and the public, supporting research and prevention and promoting the appropriate role of physicians in the care of patients with addiction. For more information, visit www.ASAM.org.   

 

Media Contact

Sarah Shelson

610.844.8366

sshelson@ASAM.org

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