FDA Refuses to Remove Generic Opana From Market
The agency rejected a request from the painkiller's manufacturer to outlaw generic versions lacking tamper-resistant features just weeks after deciding the opposite way for generic versions of OxyContin.
The agency rejected a request from the painkiller’s manufacturer to outlaw generic versions lacking tamper-resistant features just weeks after deciding the opposite way for generic versions of OxyContin.
The FDA has determined that generic versions of the painkiller Opana (oxymorphone) Extended-Release can remain on the market, rejecting a petition from Opana’s manufacturer, Endo Health Solutions. In
Endo had filed the petition to outlaw generic versions of Opana ER, which went on the market earlier this year, based on the rationale that they lacked these tamper-resistant features. The agency determined that, while the reformulated version of Opana ER has demonstrated increased ability to resist crushing, its extended-release features can be circumvented by cutting, grinding, or chewing.
In addition, the agency noted that the reformulated Opana ER can be easily prepared for injection, contrary to Endo’s claims. Indeed, there is some evidence that, compared with the original version of Opana ER, a greater portion of abuse with the reformulated version involves injection. The reformulated version also appears to be easily rendered snortable.
The FDA’s decision came just a few weeks after it
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