regulatory standards of the agency, but the FDA determined that the new data didn’t show that the altered formula could meaningfully reduce abuse. They also declined Endo’s request to label the drug describing its potential abuse-deterrent properties.
In their statement, the agency said that they now have more information about the risks of the new version of the product and will be taking steps to remove Opana ER from the market.
The FDA intends to take further steps to formally require its removal by withdrawing their approval. The agency is also making health care professionals aware of the risks associated with the drug.
In a response to the statement from the FDA, Endo decided to voluntarily withdraw Opana ER from the market. Endo said that they feel a responsibility to improve the care of pain for their patients and to take comprehensive steps to minimize the misuse of their products. They added that they’re reviewing the request and evaluating the range of options they have before they determine a path forward.
