12:00 AM
 | 
Sep 10, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Crush-resistant Opana ER oxymorphone regulatory update

Endo submitted 2 Citizen's Petitions to FDA asking the agency to require any ANDAs referencing pain drug Opana ER oxymorphone contain data and information demonstrating the generic is similarly crush-resistant as the reformulated Opana ER. Additionally, Endo asked the agency to determine...

Read the full 190 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Week In Review

Article Purchase

$30 USD
More Info >