FDA denies request to block generic Opana
The U.S. Food and Drug Administration on Friday denied a request by Endo Health Solutions to block generic versions of its prescription pain pill Opana ER -- a decision that the drug company argued would lead to more abuse than its brand name medication.
The decision came as a surprise because the FDA had recently issued tougher guidelines aimed at preventing pain pill abuse -- and had signaled that easily abused drugs would no longer reach the market.
The FDA's decision means generic versions of the heavily abused drug Opana can now be produced without tamper-resistant features that make abuse more difficult.
Last month, the agency announced it would not approve generic versions of OxyContin without tamper-resistant features -- a move experts believed all but guaranteed a similar ruling on Opana.
Endo reformulated Opana -- an opioid drug containing oxymorphone -- with tamper-resistant features last year, in an effort to make the pills harder to crush, snort and inject. Their request to block generic versions for safety reasons would have protected its expiring patent on Opana, and blocked potential competitors from copying the drug.
But the FDA announced Friday it had denied Endo's petition, in part, the agency said, because the reformulated version of Opana can still be abused and may be easier to inject than the original. Endo said it was disappointed with the decision.
Prescription drug abuse is an epidemic on Long Island and nationwide, where it leads to more overdose deaths than heroin and cocaine combined, according to the FDA.