Why was opana reformulation

Unlike the case with Opana, the FDA declared last month that original OxyContin was pulled from the market for safety reasons , and therefore generic formulations based on that original recipe would not be allowed. The agency also updated the current labeling on the reformulated OxyContin to convey that it does indeed have abuse-deterrent properties at that time. OxyContin drugmaker Purdue Pharma voluntarily withdrew the original OxyContin formulation from the market after the abuse-deterrent version became available in Endo Pharmaceuticals had taken several steps to block generics based on its original formulation from hitting the market, including the unusual step of claiming that the first incarnation of the product was unsafe.

In the company sued the FDA to block such generics, filed citizen's petitions with the agency, and filed lawsuits against several generics companies. One of those companies, Impax Labs, has been shipping generic Opana based on the original formulation since the patent expired at the beginning of this year.

After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder thrombotic microangiopathy.

This decision follows a March FDA advisory committee meeting where a group of independent experts voted that the benefits of reformulated Opana ER no longer outweigh its risks. Opana ER was first approved in for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. In , Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.

Now, with more information about the risks of the reformulated product, the agency is taking steps to remove the reformulated Opana ER from the market.

Should the company choose not to remove the product, the agency intends to take steps to formally require its removal by withdrawing approval.