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.
“It’s a high public health priority for FDA to remove these unapproved products from the market to minimize consumer exposure to drugs that may be unsafe, ineffective, and of poor quality,” said Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Since FDA-approved versions of these oral dosage forms are available by prescription, there should be no negative impact on consumers as a result of this action and no disruptions to the drug supply.”
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.
Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of prescription drug products to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.
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, products that give off electronic radiation, and for regulating tobacco products.
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