Indivior Pharmaceuticals, Inc 6-K, filed Feb 12, 2025
Indivior Pharmaceuticals, Inc. (INDV)
6-K
2025-02-12
For: 2025-02-12
View Original
Added on
April 10, 2026
About this 6-K
Indivior Pharmaceuticals, Inc filed this 6-K on February 12, 2025.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
________________________
Washington, D.C. 20549
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FORM 6-K
_____________________
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)
_______________________________
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 ☐
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EXHIBIT INDEX
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Exhibit No.
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Description of Exhibit
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99.1
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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.
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Indivior PLC
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Date: February 12, 2025
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/s/
Kathryn Hudson
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Name:
Kathryn Hudson
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Title:
Company Secretary
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Exhibit
99.1
RNS STATEMENT RE:
DELAYED FDA APPROVAL of SUBLOCADE LABEL CHANGES
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RELEASE DATE:
FEBRUARY 12, 2025
RELEASE TIME:
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.
-ends-