NDA 022410/S-042
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`SUPPLEMENT APPROVAL
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`Indivior Inc.
`10710 Midlothian Turnpike, Suite 125
`North Chesterfield, VA 23235
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`Attention:
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`Rachel Capone, MSHS
`Manager, Regulatory Affairs
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`Dear Ms. Capone:
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`Please refer to your supplemental new drug application (sNDA) dated and received
`August 21, 2020, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Suboxone (buprenorphine and naloxone) sublingual film.
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`We also refer to our letter dated July 23, 2020, notifying you, under Section 505(o)(4) of
`the FDCA, of new safety information that we believe should be included in the labeling
`for opioid analgesic products used in the outpatient setting and products approved for
`medication-based treatment of opioid use disorder. This information pertains to the risk
`of fatal overdose to patients and their close contacts who may be at elevated risk of
`opioid overdose, and that increasing access to FDA-approved naloxone for some
`patients at elevated risk may help reduce the risk of fatal opioid overdose.
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`This sNDA provides for revisions to the labeling for Suboxone, consistent with our July
`23, 2020, letter.
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`APPROVAL & LABELING
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`We have completed our review of this application. It is approved, effective on the date of
`this letter, for use as recommended in the enclosed agreed-upon labeling, which
`contains minor editorial revisions.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`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.
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`Reference ID: 4756504
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` NDA 022410 /S-042
`Page 2
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`CONTENT OF LABELING
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` As soon as possible, but no later than 14 days from the date of this letter, submit the
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`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
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`labeling.
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`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
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`The SPL will be accessible from publicly available labeling repositories.
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`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).
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`PROMOTIONAL MATERIALS
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`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
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`Prescription Drugs.3
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`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
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` Instructions for completing the form can be found at FDA.gov.5
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` 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
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`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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` 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
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`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4756504
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` NDA 022410 /S-042
`Page 3
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`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).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call LCDR Jessica Voqui, PharmD, MS, Safety Regulatory
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`Project Manager, at (301) 796-2915.
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`Sincerely,
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`{See appended electronic signature page}
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`LCDR 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
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`ENCLOSURES:
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` Content of Labeling
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` Medication Guide
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4756504
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`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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`/s/
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`MARK A LIBERATORE
`03/04/2021 09:19:09 AM
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`Reference ID: 4756504
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