FDA bans generic copies of painkiller OxyContin
Markus MacGill
pharmaphorum
In a controversial decision that hands a victory to Purdue Pharma, the US Food and Drug Administration has banned copycat versions of the maker’s painkiller OxyContin (oxycodone).
The opiate drug has just lost its patent protection but the regulatory body has prevented the sale of generic copies over fears of misuse due to the drug’s potential for addiction. The branded product is sold in tamper-resistant form that is less likely to be abused.
“The development of abuse-deterrent opioid analgesics is a public health priority for the FDA.”
Douglas Throckmorton, deputy director for regulatory programmes, FDA Center for Drug Evaluation and Research.
The FDA has approved updated labelling on the branded product after Purdue improved resistance to the drug being crushed or dissolved and misused, and provided data to support this improvement.
“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.”
Douglas Throckmorton, FDA deputy director.
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Related news:
Fearing abuse, FDA blocks generic OxyContin (Yahoo! News)
FDA bans generic version of OxyContin (Fox News)
FDA puts halt to generic OxyContin (FiercePharma)
Should FDA Have Barred Generic OxyContin? (Pharmalot)
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