FDA Bans Generics of Purdue’s Older OxyContin Painkiller

Generic-drug companies will be barred from making copies of older versions of OxyContin that don’t have tamper-resistant qualities, U.S. regulators said.

The Food and Drug Administration determined today that closely held Purdue Pharma LP, maker of a reformulated OxyContin, pulled previous versions of the popular painkiller without abuse-deterrent measures from the market for safety or effectiveness reasons. The determination will keep generic drugmakers such as Teva Pharmaceutical Industries Ltd. and Impax Laboratories Inc. from making copies of the older version.

Generic drugmakers had been waiting for the expiration today of a patent on the original OxyContin. Stamford, Connecticut-based Purdue Pharma pulled that version from U.S. pharmacy shelves and replaced it with a tamper-resistant formulation in August 2010 after reports of widespread abuse. The newer drug is still under patent protection.

“The data show that, when compared to original OxyContin, reformulated OxyContin has an increased ability to resist crushing, breaking, and dissolution using a variety of tools and solvents,” the FDA said in the notice posted in the Federal Register.

Endo Health Solutions Inc. is seeking a similar determination from the FDA regarding its old painkiller Opana, which the Chadds Ford, Pennsylvania-based company had pulled and reformulated with abuse-deterrent features. Impax currently sells a generic version of the original Opana.

Endo Gains

Endo gained 5 percent to $36.60 in extended trading at 5:56 p.m. New York time. The shares had increased 1.7 percent during regular trading to close at $34.86.

The FDA also approved labeling for reformulated OxyContin that indicates the product has physical and chemical properties that make abuse via injection difficult and are expected to reduce abuse from snorting, the agency said in a statement.

“Purdue Pharma is pleased with the FDA’s approval of this new language for the OxyContin label, which will provide important information to health-care professionals,” Gary Stiles, the company’s senior vice president of research and development, said in a statement.

(Updates with Purdue Pharma comments in eighth paragraph.)
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