Indivior Faces Delayed FDA Approval for SUBLOCADE Label Changes
Why we think this is neutral
The RNS announcement regarding the delayed FDA approval of SUBLOCADE label changes is a regulatory update with no immediate material impact on Indivior's business. While the delay is a minor setback, the fact that the proposed changes have been accepted by the FDA suggests the approval is likely to be granted eventually. Broker targets remain positive on the company's prospects, indicating the market views this as a temporary issue.
Key Points
- FDA has delayed approval of label changes for SUBLOCADE product
- Proposed label changes have been accepted by FDA, suggesting approval likely
- Brokers maintain positive outlook on Indivior, with buy recommendations and price targets above current share price
Summary
Indivior PLC has announced that the FDA has delayed the approval of label changes for its SUBLOCADE (buprenorphine extended-release) Injection product. The FDA has informed Indivior that, following acceptance of the proposed label changes, there are no outstanding items to address, but the final review has been delayed. Indivior will provide further updates on the status of the SUBLOCADE label change approval as appropriate.