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.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA: Novartis recall may also affect painkillers

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

Boxed warnings are common in novel therapeutics

14 hours ago

(HealthDay)—Boxed warnings are common on recent drug approvals, and many occur years after approval, according to a research letter published online Aug. 15 in JAMA Internal Medicine.

AstraZeneca says DOJ closes probe into drug trial

15 hours ago

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action.

Perampanel for epilepsy: Still no proof of added benefit

16 hours ago

The drug perampanel (trade name Fycompa) has been approved since July 2012 as adjunctive ("add-on") therapy for adults and children aged 12 years and older with epileptic fits (seizures). In a new early benefit assessment ...

User comments