The pill became notorious after it was blamed for prompting an HIV outbreak in rural in in 2015, and it was also linked to reports of a rare but serious blood disease characterized by clots that can lead to organ damage.
The move marks the first time the agency has called for the removal of an opioid painkiller for public health reasons and comes after a panel of advisers concluded in March that the drug's benefits did not outweigh the risks. Endo shares, which were up 11 percent at the close of the stock market, fell more than 12 percent in after-hours trading.
In a statement, the company said it was reviewing the FDA's request but that it "remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients". When the company submitted its reformulated version to the FDA in 2012, the agency decided the data weren't strong enough to show that it could "meaningfully reduce abuse", and the agency denied a request to include a label that would describe its reformulation as having abuse-deterrent properties.
If Endo refuses to withdraw the product, the FDA could offer the company an opportunity for a hearing to make the case for why the product should not be removed.
Endo first got US approval for its extended-release opioid, Opana ER, in 2006. Most claim the drugmakers oversold the benefits and downplayed the risks in their marketing of the drugs to the public and doctors.
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Opana ER, a potent extended-release opioid, was approved by the FDA for pain management in 2006.
"When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market", Woodcock added in a statement.
"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak", said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "This action will protect the public from further potential for misuse and abuse of this product". Despite the advisory committee vote in March, Endo said that more than half the panel members "expressed their preference that Opana ER remain on the market, but with additional regulatory restrictions to mitigate the risks of misuse and abuse". However, the company came under fire from both the FDA and the state of NY for not making significant changes that reduced the risk of abuse. The agency said it would take formal action to remove the product from market if Endo Pharmaceuticals denies the FDA's request.
Opana ER brought in $158 million in sales previous year for Endo, a 10 percent drop from 2015 because of generic competition, according to FiercePharma, a trade site.
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