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U.S. Department of Health and Human Services

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Questions and Answers for Consumers about FDA's Action Involving Unapproved Oxycodone Single-Ingredient, Immediate Release Drug Products for Oral Administration

What action is FDA taking today?

The FDA is announcing its intent to take enforcement action against companies that manufacture or distribute unapproved single-ingredient, immediate-release oral drug products containing oxycodone hydrochloride, labeled for human use. 

Consumers should be aware that approved versions of these drugs will remain available.

 

Why is FDA taking this action?

These products have been associated with reports of medication errors causing serious adverse events. In addition, some unapproved products omit important warning information in their labeling. This action is part of FDA’s continuing effort to ensure that new drugs marketed in the United States have the required FDA approval, which means that they have been found to be safe, effective, of good quality, and appropriately labeled.

 

What effect will FDA’s action have on people who currently use these oxycodone products?

Consumers will continue to have access to FDA-approved oxycodone products. There are FDA-approved versions of these drug products on the market that contain the same active ingredient, strength(s), and dosage forms as the unapproved products. All of the manufacturers of the approved versions of these products have given FDA assurances that they can adequately supply the market.

 

Some of these products have been on the market so long, why take them off now? 

Over the past century, the laws outlining the requirements for drug approval have changed. As a result of these changes in the law, many of the products that are the focus of the FDA action have been marketed without being approved under the current legal requirements. Many health care providers have been unaware of the unapproved status of these drug products and have unknowingly prescribed them because the drugs’ labeling does not disclose that they lack FDA approval. Currently, the law requires that new drugs be shown to be safe, effective, adequately labeled, and of appropriate manufacturing quality prior to being approved by FDA for marketing in the United States. In an attempt to address this issue, the FDA’s Unapproved Drugs Initiative, which began in 2006, has been systematically targeting marketed unapproved drugs and removing them from the market.

 

How can people tell the difference between FDA-approved and unapproved prescription products?

Health care professionals and consumers can use Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/) or the National Drug Code (NDC) Directory to determine whether a drug product is FDA-approved. Drugs@FDA contains most FDA-approved drug products. Search results from the NDC directory include a column marked “Application Number.” FDA-approved products will have an associated NDA (new drug application) or ANDA (abbreviated new drug application) number in this column.

 

Is it safe to use the unapproved products?

The safety of unapproved new drugs is unknown. Approved versions of single-ingredient, immediate-release oral drug products containing oxycodone have been specifically reviewed by FDA for safety and effectiveness.

 

Should I keep taking my medications?

The FDA cannot give medical advice to individual patients. Patients who have concerns about their medications should speak to their health care professionals.

 

Which Oxycodone drugs are being marketed without approval?

The FDA action is targeted at any company manufacturing or distributing an unapproved single-ingredient immediate-release oral drug product containing oxycodone hydrochloride.
 
The table below contains National Drug Code (NDC) numbers of unapproved single-ingredient immediate-release oxycodone drug products. The NDC numbers on this list were obtained from FDA’s Drug Registration and Listing System (DRLS) in July 2012.
 
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register and list all of their commercially marketed drug products with the FDA. The list below of unapproved prescription single-ingredient oxycodone immediate-release products may include drugs that are no longer being marketed and/or may not include drug products that are currently being marketed if the firm has not listed or updated its information with DRLS. 

0527-1426
10609-1614
0527-1774
10609-1615
54868-3932
63629-3763
0406-8555
54868-5507
0406-8558
0115-7026
0406-8668
48692-006
0406-554
10702-023
0056-132
66689-024
0756-263
68071-266
0756-292
58177-315
0756-293
68462-348
0756-294
65893-850
0756-357
0756-023
 

 

 

 

 

 

 

 

 

 

 

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