`f ~ Ii U.S. FOOD & DRUG
`
`ADMINISTRATION
`
`\.,~ ~
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`NDA 022410/S-049
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`
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`SUPPLEMENT APPROVAL
`
`
`Indivior Inc.
`2579 Midpoint Drive
`Fort Collins, CO 80525
`
`Attention: Mehul Punamiya, MSc
`Director, Global Regulatory Strategy and CMC
`
`
`
`Dear Mr. Punamiya:
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`January 6, 2023, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Suboxone (buprenorphine and naloxone) sublingual film.
`
`This Prior Approval sNDA provides for the removal of labeling language related to the
`Drug Addiction Treatment Act of 2000 (DATA 2000) waiver requirement for prescribers,
`in order to align with the enactment of the Mainstreaming Addiction Treatment (MAT)
`Act of 2021,1 which repeals the DATA 2000 waiver requirement.
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is 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.
`
`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.2 Content of labeling must be identical to the enclosed labeling (Prescribing
`information), 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.
`
`
`1 Section 1262 of the Consolidated Appropriations Act, 2023 (also known as Omnibus bill)
`
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` 2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 5140714
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`
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`NDA 022410/S-049
`Page 2
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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.3
`
`
`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.4
`
`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.5 Information and
`
` Instructions for completing the form can be found at FDA.gov.6
`
`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
`
`
`3 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.
`
` 4 For the most recent version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/media/128163/download.
`
`
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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`6 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: 5140714
`
`
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`NDA 022410/S-049
`Page 3
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`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 Joyce Chin, Pharm.D., Regulatory Health Project
`Manager, at (301) 348-1772.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Rigoberto Roca, MD
`Division Director
`Division of Anesthesiology, Addiction Medicine, and
`Pain Medicine
`Office of Neuroscience
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE:
` Content of Labeling
`o Prescribing Information
`
`
`
`
`
`
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5140714
`
`
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`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.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`RIGOBERTO A ROCA
`03/13/2023 02:49:27 PM
`
`Reference ID: 5140714
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