Health Canada approves another generic oxycodone tablet
December 2, 2013
Health Canada has approved another generic form of oxycodone, this time from Ranbaxy Laboratories. In late-2012, six pharmaceutical manufacturers received approval from Health Canada for a controlled-release formulation of oxycodone, essentially a generic form of OxyContin. In the U.S., the original OxyContin manufactured by Purdue Pharma was reformulated in 2010 to include new tamper-resistant features in an effort to make the tablets harder to abuse. In early 2012, Purdue began to market this new abuse-resistant formulation in Canada under the name of OxyNEO.
Generic versions of OxyContin have been banned in the United States by the FDA because they are too easily crushed and snorted or injected, and only the newer formulation of OxyContin bearing the imprint 'OP' are sold there. The U.S. is dealing with a painkiller abuse epidemic that is killing tens of thousands of people a year. According to a recent article in the Globe and Mail, the U.S. has begun seeing generic oxycodone CR tablets coming in from Canada, and they have been putting pressure on Canada to outlaw generic versions of oxycodone.
Health Canada approves addictive form of oxycodone as U.S. urges ban
The Globe and Mail - Nov. 27, 2013Health Canada recently approved a generic, addictive form of oxycodone just as U.S. officials were urging their Canadian counterparts to ban such formulations of the powerful painkiller. The green light to Ranbaxy, India's biggest drug maker, came soon after the White House Office of Drug Control Policy reminded Health Minister Rona Ambrose of the dangers posed by generic forms of the opioid. The U.S. has been pressing Canada to outlaw generic oxycodone, citing studies that show the more addictive formulations are migrating south of the border.
Health Canada, meantime, defended itself, saying it "rigorously" assesses every drug's safety and efficacy before approving it. "These decisions are made by experts in the department based on science; the minister is not consulted on day-to-day drug approvals," said spokeswoman Leslie Meerburg. She added Health Canada is working to help companies develop tamper-resistant opioid formulations that might help reduce the risk of abuse.
This news comes at the same time as the results of a recent survey published in the current issue of the journal PAIN indicate that oxycodone is the preferred drug of choice among prescription opioid abusers. Of the more than 3,500 opioid-dependent individuals in drug-treatment programs across the United States who were surveyed, 45 percent indicated oxycodone to be their favored drug of choice. A majority of the oxycodone abusers reported snorting or injecting the crushed pills. Hydrocodone, the opioid in Vicodin, was preferred by 30 percent of the respondents. An article with the full results of the survey is available on the