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FDA Clears 2 Generic Forms of OxyContin
    #2466996 - 03/24/04 11:35 AM (16 years, 9 months ago)


WASHINGTON (Reuters) - U.S. regulators approved two generic versions of the often-abused painkiller OxyContin on Tuesday after the makers agreed to take steps to prevent illegal use.

The Food and Drug Administration (news - web sites) cleared generic forms of the prescription pain pill made by Teva Pharmaceutical Industries and Endo Pharmaceutical Holdings, an agency spokeswoman said.

Privately held Purdue Pharma makes the brand-name version.

"In approving these generic products, the 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," the agency said in a statement.

OxyContin is used to treat moderate to severe pain from cancer and other illnesses. It is formulated to relieve pain over 12 hours, but abusers crush the pill to snort or inject it for a quick high.

To prevent misuse, the generic manufacturers agreed to safeguards similar to those put in place by the brand-name maker, the FDA said.

Purdue Pharma's measures have included educating prescribers, pharmacists and patients about safe use of OxyContin and surveillance of possible abuse or diversion.

Generic versions of prescription drugs usually are much cheaper than their brand-name counterparts. The FDA said its research shows the arrival of generic copycats does not increase use of a drug.

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Re: FDA Clears 2 Generic Forms of OxyContin [Re: Seuss]
    #2467438 - 03/24/04 01:39 PM (16 years, 9 months ago)

>>>To prevent misuse, the generic manufacturers agreed to safeguards similar to those put in place by the brand-name maker, the FDA said.

I wonder if/when they are going to start putting microencapsulated naltrexone/naloxone in the Oxycontin, and generic, pills.  I remember reading about that somewhere, maybe Erowid.  It also said that it looked like it would be a few more years before something like this could be implemented, but it was dated material.  And if they did add it, I think a cold water extraction on an uncrushed pill would separate the oxycodone from the insoluble beads of naloxone.  Maybe this is the dilemma Purdue is having.

*Google is useful :smile2:
"One method under consideration is to put the narcotic blocker naloxone in OxyContin tablets. If the tablets are crushed and injected, naloxone would enter the bloodstream to block the OxyContin's effects. That wouldn't block other forms of abuse, but Purdue Pharma had called it an important interim step that it hoped to begin selling next year. A competing painkiller, Talwin NX, uses that approach.

But Tuesday, Purdue Pharma announced that clinical trials found, among other problems, that naloxone sometimes blocked pain relief for patients who took the combination tablets correctly. Purdue Pharma said it won't be seeking Food and Drug Administration approval this year, and will do further research to see if naloxone is worth pursuing."
Oxycontin Addiction Side Effects Lawsuit


Edited by AuroricDistortions (03/24/04 01:42 PM)

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