FDA denies request to block generic painkiller

In a surprise move, federal health regulators have denied a request by Endo Health Solutions to block generic versions of its painkiller Opana ER, which the company argued can be more easily abused than its branded product.

Endo's Opana ER is a long-acting narcotic used to treat moderate and . Such medications are frequently crushed and then injected or snorted by drug abusers to achieve a euphoric effect.

Last year, Endo reformulated Opana with the aim of making the pills more difficult to crush. The company also hoped the move would protect its expiring patent on Opana by blocking approval of based on the original formulation.

But the FDA said late Friday that it denied the petition, pointing out that Endo's reformulated drug can still be abused.

Related Stories

FDA: Novartis recall may also affect painkillers

date Jan 09, 2012

(AP) -- The Food and Drug Administration is warning patients about a potential mix-up between powerful prescription pain drugs and common over-the-counter medications like Excedrin and Gas-X made at a Novartis manufacturing ...

Recommended for you

FDA clears drug for leading form of cystic fibrosis

date Jul 02, 2015

Federal health officials have approved a new combination drug for the most common form of cystic fibrosis, the debilitating inherited disease that causes internal mucus buildup, lung infections and early death. But it will ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.