Event
FDA approval of OxyContin (1995)
The FDA's 1995 approval of Purdue's OxyContin, with a label saying its design was believed to reduce abuse liability.
- Dates
- 1995
Connections 4
involved
- U.S. Food and Drug Administration approved the drug Scholarship & press 1
- Curtis Wright examiner who oversaw the review Scholarship & press 1
- David Kessler commissioner at the time; says he was not involved in the approval Scholarship & press 1
- OxyContin Scholarship & press 1
Timeline 1 date
- 1995 FDA approval of OxyContin (1995)
Proof 1 source
-
The Family That Built an Empire of Pain, The New Yorker, 23 Oct 2017.
Scholarship & press
The F.D.A. approved OxyContin in 1995, for use in treating moderate to severe pain.
The F.D.A. examiner who oversaw the process, Dr. Curtis Wright, left the agency shortly afterward.
David Kessler, who ran the F.D.A. at the time, told me that he was “not involved in the approval.”
Purdue had conducted no clinical studies on how addictive or prone to abuse the drug might be.
absorption mechanism “is believed to reduce the abuse liability.”
But the F.D.A., in an unusual step, approved a package insert for OxyContin
Page history 1 change
- Add 55 stories, each checked against its sources96e92fe6
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