Although Orexigen Therapeutics Inc. failed in its latest bid to persuade FDA’s Center for Drug Evaluation and Research to consider approving Contrave (naltrexone/bupropion) before results come in from a dedicated cardiovascular outcomes study, the company believes the response received from the agency puts it on a path to a speedier NDA resubmission for the obesity agent.
Orexigen acknowledges that procedural details for an earlier resubmission need to be worked out with the agency. Nevertheless, the company...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?