FDA bans crushable generic OxyContin
NEWS IN BRIEF — Posted April 29, 2013
The Food and Drug Administration will not approve generic versions of OxyContin that can be crushed easily into a powder for snorting or altered and be put into an injection, federal officials announced April 16.
The therapeutic benefits of original OxyContin (oxycodone hydrochloride), first approved in 1995, no longer outweigh risks for abuse, the FDA said in its decision. The original version of the drug was withdrawn from sale by the manufacturer Purdue Pharma in 2010, but the development of generics based on the 1995 version could re-emerge on the market. Newer versions are more difficult to crush, break or dissolve, the FDA said.
Lawmakers and enforcement officials had pressed the FDA to deny approval of generic opioids that are not tamper-resistant. An estimated 16,000 Americans die of opioid overdoses each year.
“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA Center for Drug Evaluation and Research. “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.”