NDA 022410/S-046, S-047
`
`
`
`Indivior, Inc.
`10710 Midlothian Turnpike
`Suite 125
`North Chesterfield, Virginia 23235
`
`Attention: Alexis Williams, PharmD
`Global Regulatory Strategy & CMC Manager
`
`SUPPLEMENT APPROVAL
`
`
`
`
`Dear Dr. Williams:
`
`Please refer to your supplemental new drug applications (sNDAs) dated and received,
`February 11, 2022, and April 28, 2022, and your amendments, submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Suboxone
`(buprenorphine and naloxone) sublingual film.
`
`We also refer to our letter dated January 12, 2022, notifying you, under Section
`505(o)(4) of the FDCA, of new safety information that we believe should be included in
`the labeling for transmucosal buprenorphine-containing products. This information
`pertains to the risk of dental caries.
`
`Finally, we also refer to our letter dated March 31, 2022, notifying you, under Section
`505(o)(4) of the FDCA, of new safety information that we believe should be included in
`the labeling for buprenorphine-containing products. This information pertains to the risk
`of QT prolongation.
`
`These supplemental new drug applications provide for revisions to the labeling for
`Suboxone, consistent with our January 12, 2022, and March 31, 2022, letters.
`
`APPROVAL & LABELING
`
`We have completed our review of these applications, as amended. They are approved,
`effective on the date of this letter, for use as recommended in the enclosed agreed-
`upon labeling.
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
`
`
`Reference ID: 5000664
`
`

`

`NDA 022410/S-046, S-047
`Page 2
`
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling, with the
`addition of any labeling changes in pending “Changes Being Effected” (CBE)
`supplements, as well as annual reportable changes not included in the enclosed
`labeling.
`
`Information on submitting SPL files using eList may be found in the guidance for
`industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications that include labeling
`changes for this NDA, including CBE supplements for which FDA has not yet issued an
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
`Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`Prescription Drugs.3
`
`You must submit final promotional materials and Prescribing Information, accompanied
`by a Form FDA 2253, at the time of initial dissemination or publication
`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`Instructions for completing the form can be found at FDA.gov.5
`
`
`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`3 For the most recent version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/media/128163/download.
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5000664
`
`

`

`NDA 022410/S-046, S-047
`Page 3
`
`
`All promotional materials that include representations about your drug product must be
`promptly revised to be consistent with the labeling changes approved in this
`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
`in your promotional materials should include prominent disclosure of the important new
`safety information that appears in the revised labeling. Within 7 days of receipt of this
`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
`
`PATENT LISTING REQUIREMENTS
`
`
`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
`submitted in a supplement require you to submit patent information for listing in the
`Orange Book upon approval of the supplement. You must submit the patent information
`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
`applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
`supplement for the patent information to be timely filed (see 21 CFR 314.53(c)(2)(ii)).
`You also must ensure that any changes to your approved NDA that require the
`submission of a request to remove patent information from the Orange Book are
`submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
`314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call LCDR Jessica Voqui, PharmD, MS, Associate Director
`for Postmarket Regulatory Science, at 301-796-2915.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`CDR Mark A. Liberatore, PharmD, RAC
`Deputy Director for Safety
`Division of Anesthesiology, Addiction Medicine,
`and Pain Medicine
`Office of Neuroscience
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURES:
` Content of Labeling
`o Prescribing Information
`o Medication Guide
`o
`Instructions for Use
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5000664
`
`

`

`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
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`MARK A LIBERATORE
`06/17/2022 07:54:32 AM
`
`Reference ID: 5000664
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