WASHINGTON (April 16, 2013)—The U.S. Food and Drug Administration will require generic versions of the best-selling painkiller OxyContin to include recent formulation changes designed to make the pill harder to abuse.
The FDA says it won’t approve any generic versions of OxyContin based on the original formulation because it "poses an increased potential for certain types of abuse."
The FDA decision is a key victory for Purdue Pharma LP, which has spent years developing a tamper-resistant version of the blockbuster pain pill.
The company's patent on original OxyContin expired Tuesday and that would normally open the door to a slew of cheaper generic versions.
However, the FDA decision effectively protects Purdue from lower-price competition by requiring generic manufacturers to develop their own abuse-deterrent designs.
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