FDA Will Not Approve Generic Versions of Original OxyContin
The Food and Drug Administration (FDA) announced Tuesday it
will not approve any generic versions of the original form of
OxyContin. The move is aimed at preventing prescription drug abuse, Reuters reports. The original version of OxyContin could be crushed and then snorted or injected. Its patent was set to expire on Tuesday.
The FDA also approved new labeling for a reformulated version of the
drug, which will indicate it is more difficult to crush, and thus harder
to abuse than the original version. OxyContin’s manufacturer, Purdue
Pharma, introduced the tamper-resistant formula in 2010.
“The development of abuse-deterrent opioid analgesics is a public
health priority for the FDA,” Douglas Throckmorton, MD, Deputy Director
for Regulatory Programs in the FDA’s Center for Drug Evaluation and
Research, said in a statement.
“While both original and reformulated OxyContin are subject to abuse
and misuse, the FDA has determined that reformulated OxyContin can be
expected to make abuse by injection difficult and expected to reduce
abuse by snorting compared to original OxyContin.”
Representative Hal Rogers of Kentucky, Co-Chairman of the Congressional Caucus on Prescription Drug Abuse, said in a statement,
“This is a huge win for our region and for the thousands of families
who have seen painkillers become pain makers. The FDA undoubtedly saved
our nation from another deadly tidal wave of oxycodone abuse and
overdoses.”
