The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA prompts companies to remove certain unapproved oxycodone products from market FDA today issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone. The notice is part of the FDA’s Unapproved Drugs Initiative to remove unapproved new drugs from the market. The FDA action affects companies that manufacture and distribute unapproved single-ingredient, immediate-release oxycodone drug products in oral dosage forms, including tablets, capsules and oral solutions. These products have not been evaluated by the FDA for safety, effectiveness, manufacturing quality, or appropriate labeling, including dosing information and warnings, and cannot be legally marketed in the United States. Oxycodone is an opioid analgesic, a class of powerful pain medications. Oxycodone is listed under Schedule II of the Controlled Substances Act with an abuse liability similar to other opioid agonists. Improper labeling and use of oxycodone can lead to overdose and death. FDA recognizes that opioid medications are associated with prescription drug misuse, abuse, and addiction, which have resulted in an increase in injuries and deaths across the United States over the last 10 years. The FDA’s Unapproved Drugs Initiative, which began in June 2006, is the agency’s risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process. One of the goals of the initiative is to reduce consumer exposure to drugs that are not proven safe, effective, and of high quality. Companies with certain products that are subject to this action are expected to stop manufacturing the products within 45 days and stop shipping the products within 90 days. Products that are subject to these timeframes are products that: - were introduced onto the market before Sept. 19, 2011, - were listed in the FDA’s Drug Registration and Listing System before July 6, 2012, and - were being commercially used or sold before July 6, 2012. Companies that continue to market products that fall within this scope of this Federal Register notice are subject to enforcement action including seizure, injunction, or other judicial or administrative proceeding. For more information please visit: Oxycodone
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM. Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
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