Abbott Laboratories sought FDA approval for an extended-release version of Vicodin, a painkiller. Recently, the FDA decided not to approve the extended-release Vicodin. Through a controlled-release mechanism, the new formulation was meant to provide pain relief for over 12 hours, rather than the 4-6 hour relief period of short-acting pain relievers. Concern for the potential for abuse of painkillers like Vicodin, has been expressed by doctors and consumer groups. Abbott projected eventual annual sales of $500 million for extended-release Vicodin. However, there is a current climate of intense scrutiny of drug approvals following high profile problems with drug recalls such as the painkiller Vioxx. Hopefully, the FDA is being more careful in its approval process, which will avoid drugs being rushed to market with inadequate safety profiles. Abbott plans to evaluate the FDA response and communicate with the agency regarding its decision.
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.
Comments for this article are closed.