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FDA Statement

Statement on Generic Oxycodone Hydrochloride Extended Release Tablets

The Food and Drug Administration today released the following statement on its approval of generic oxycodone hydrochloride extended-release tablets:

Oxycodone hydrochloride extended-release products, such as OxyContin and its generic versions, are important options for the management of moderate-to-severe chronic pain, such as that associated with cancer and various other illnesses. FDA's approval of two generic oxycodone hydrochloride products should make this safe and effective medicine available at a lower cost to patients suffering from moderate to severe chronic pain.

At the same time, FDA recognizes that oxycodone extended-release tablets present a potential for abuse, misuse, and diversion. That is why FDA has secured the agreement of the manufacturers of the generic products to have in place, prior to marketing, risk management plans that are consistent with the innovator product's plan.

Decades of experience with generic drug approvals suggest that, when the first generic versions of an innovator drug reach the market, the use of that drug does not increase overall. Rather, demand tends to remain steady, with an increasing proportion of market share being held by the generic versions.

Earlier this month, the Office of National Drug Control Policy, the DEA, and FDA announced a coordinated strategy to confront the illegal diversion and abuse of prescription drugs. This coordinated strategy includes:

• Careful consideration of labeling and commercial promotion of opiate drug products;
• Ensuring wider dissemination of education and training on appropriate pain management and opioid treatment procedures for physicians authorized to prescribe controlled substances;
• Increasing the number of state Prescription Monitoring Programs, which detect suspicious prescriptions and individuals redeeming prescriptions from multiple physicians ("doctor shopping") to identify abusers; and
• Using web crawler/data mining technology to identify, investigate and prosecute "pill mills" - Internet pharmacies that provide controlled substances illegally

Today's announcement incorporates education of medical professionals and consumers, outreach to businesses involved in Internet commerce, pharmaceutical manufacturers, and pharmacies, as well as increased investigation and enforcement activities.

When used correctly, opioids play a very important role in the management of pain. FDA's job is to maximize the potential benefits that patients receive from these drugs, while, at the same time, minimizing the risks associated with these products. FDA takes its responsibility in meeting this challenge very seriously.

In approving these generic products, FDA is seeking to balance the need for effective pain management therapies -- for the more than 10 million Americans who suffer from chronic pain -- with the prevention of misuse, abuse, and diversion of prescription drugs.

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