Endo announced the completed transition of its Opana ER (oxymorphone HCl extended-release) tablets to the new formulation designed to be crush-resistant. The FDA has now moved the old formulation and all strengths of Opana ER to the Orange Book Discontinued List.
The original formulation was deemed safe and effective, but it was subject to both intentional and inadvertent abuse and misuse. The new formulation of Opana ER (under NDA 201655) remains on the approved prescription drug product list as it is the only currently available formulation. The biconcave tablets come in 5mg, 10mg, 20mg, 30mg, and 40mg dosage strengths.
Opana ER is a Class II opioid narcotic indicated for moderate to severe pain when the use of a continuous, around-the-clock opioid is required for an extended period of time; it is not for an “as-needed” use.
For more information call (800) 462-ENDO or visit www.opana.com.