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Indivior Statement RE: Delayed FDA Approval of SUBLOCADE® Label Changes

1. Indivior's PDUFA action date for SUBLOCADE has been delayed. 2. FDA accepted the proposed label changes with no outstanding items. 3. Final review for label changes is postponed; updates will be provided.

FDA Approval
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FAQ

Why Bearish?

The delay in the review process may hinder potential revenue growth from SUBLOCADE.

How important is it?

The delay directly impacts the timeline for product approval, affecting future sales and perceptions.

Why Short Term?

Short-term delays often discourage investor confidence and impact stock price quickly.

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INDVSBUX
, /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE® (buprenorphine extended-release) Injection, which was scheduled for February 7, 2025: Yesterday, February 11th, the FDA informed Indivior that, following acceptance of the proposed label for SUBLOCADE, there were no outstanding items to address, but that final review of the SUBLOCADE label changes has been delayed. Indivior will provide further updates on the status of the approval of the proposed SUBLOCADE label changes as appropriate. SOURCE Indivior PLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In Also from this source

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