Indivior flags delay to FDA review of Sublocade label change
By Josh White
Date: Wednesday 12 Feb 2025
(Sharecast News) - Indivior announced a delay in the US Food and Drug Administration's (FDA) final review of proposed label changes for its 'Sublocade', or buprenorphine extended-release, injection on Wednesday.
The company was expecting a decision by 7 February, as per the Prescription Drug User Fee Act (PDUFA) timeline.
It said on Wednesday that the FDA informed the company on 11 February that there were no outstanding issues following acceptance of the proposed label, which includes a rapid initiation protocol and alternative injection sites.
However, the final review process has been delayed.
The company did not provide a revised timeline for approval but said it would issue further updates as appropriate.
At 0813 GMT, shares in Indivior were up 6.47% at 814.5p.
Reporting by Josh White for Sharecast.com.
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