Indivior PLC's once monthly injectable buprenorphine formulation for the treatment of opioid use disorder seems to get good marks from the US FDA on overall efficacy and safety. But the agency said it is "particularly concerned about the potential risks associated with this product" because it will be available in prefilled syringes with needles attached.
FDA raised potential safety issues with the product, RBP-6000 (buprenorphine injectable), in a briefing document for an Oct
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?