6-K
Indivior Pharmaceuticals, Inc. (INDV)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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Washington, D.C. 20549
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FORM 6-K
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Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of February 2025
Commission File Number: 001-37835
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Indivior PLC
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10710 Midlothian Turnpike, Suite 125
North Chesterfield, Virginia 23235
(Address of principal executive office)
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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
Form 20-F ☒ Form 40-F ☐
EXHIBIT INDEX
| Exhibit No. | Description of Exhibit |
|---|---|
| 99.1 | Announcement sent<br>to the London Stock Exchange on February 12, 2025, titled<br>“Delayed FDA Approval of SUBLOCADE Label<br>Changes”. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Indivior PLC | |
|---|---|
| Date: February 12, 2025 | /s/<br>Kathryn Hudson |
| Name:<br>Kathryn Hudson | |
| Title:<br>Company Secretary |
a7798w-58126621
Exhibit 99.1
RNS STATEMENT RE: DELAYED FDA APPROVAL of SUBLOCADE LABEL CHANGES
| RELEASE DATE:<br> FEBRUARY 12, 2025<br><br><br><br><br><br>RELEASE TIME:<br> 7:00 AM GMT |
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Indivior 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.
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