After expert panel vote, Endo's opioid Opana ER faces FDA restrictions—or withdrawal
Fierce Pharma ------- Endo's opioid painkiller Opana ER took a hit on Tuesday when an FDA advisory committee decided that the drug’s benefits no longer outweigh its risks. If the agency agrees, it could pull the med or restrict its use in yet another setback for the ailing drugmaker. By a vote of 18 to 8, experts at a joint FDA committee meeting determined that the opioid pain med’s benefits don’t outweigh its risks. According to Endo, some experts felt that the drug’s benefits are “overshadowed” by “misuse, abuse and diversion.” The FDA isn’t required to follow its agency’s recommendations, but it generally does. To get more in depth information click on the picture below to read the article.