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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 020732/S-020
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` NDA 020733/S-024
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`NDA 022410/S-034
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` Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` Indivior Inc.
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` 10710 Midlothian Turnpike
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` Suite 430
` Richmond, VA 2323
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` Attention:
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`
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` Rachel Capone
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`
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`Manager, Regulatory Affairs
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`Dear Ms. Capone:
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`Please refer to your Supplemental New Drug Applications (sNDAs) dated and received
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`June 28, 2018, and your amendments, submitted under section 505(b) of the Federal
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`
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`Food, Drug, and Cosmetic Act (FDCA) for NDA 020732/S-020, SUBUTEX
`(buprenorphine) sublingual tablet; NDA 020733/S-024, SUBOXONE (buprenorphine
`and naloxone) sublingual tablet; NDA 022410/S-034, and SUBOXONE (buprenorphine
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`and naloxone) sublingual film.
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`These Prior Approval Supplemental New Drug Applications propose changes to the
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`approved Medication Guide, aligning them to the changes in the package insert
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`pertaining to risks of life-threatening respiratory depression and death with concomitant
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`use of buprenorphine with benzodiazepines or other CNS depressants, and to improve
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`patient understanding of the serious risks associated with SUBOXONE sublingual film,
`SUBOXONE sublingual tablet and SUBUTEX sublingual tablet, which were approved
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`on February 1, 2018.
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`APPROVAL & LABELING
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` We have completed our review of this supplemental application, as amended. It is
` approved, effective on the date of this letter, for use as recommended in the enclosed,
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`
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` agreed-upon labeling text.
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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
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`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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`Reference ID: 4514226
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` NDA 020732/S-020
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` NDA 020733/S-024
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` NDA 022410/S-034
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` Page 2
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`
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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
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` http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
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`Content of labeling must be identical to the enclosed labeling (text for the Prescribing
`Information and Medication Guide), with the addition of any labeling changes in pending
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`“Changes Being Effected” (CBE) supplements, as well as annual reportable changes
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`
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`
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`not included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry titled “SPL Standard for Content of Labeling Technical Qs and As” at
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`
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guida
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`nces/UCM072392.pdf.
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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
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
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`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
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`Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`Reference ID: 4514226
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` NDA 020732/S-020
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` NDA 020733/S-024
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` NDA 022410/S-034
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` Page 3
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` If you have any questions, call Swati Patwardhan, Regulatory Project Manager, at 301
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` 796-4085.
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`Sincerely,
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`{See appended electronic signature page}
`
`
`Rigoberto Roca, MD
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`Deputy Director
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`Division of Anesthesia, Analgesia,
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`and Addiction products
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`Office of Drug Evaluation II
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`Content of Labeling
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`• Prescribing Information
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`• Medication Guide
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`Reference ID: 4514226
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`
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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/
`------------------------------------------------------------
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`RIGOBERTO A ROCA
`10/31/2019 09:10:50 PM
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`Reference ID: 4514226
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`(
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