`
` NDA 202788/S-020
`
`
`
`SUPPLEMENT APPROVAL
`
`
`Insys Development Co., Inc.
`1333 South Spectrum Blvd. Suite # 100
`Chandler, AZ 85286
`
`Attention:
`
`Neha Parikh
`
`Vice President, Research & Development
`
`
`Dear Ms. Parikh:
`
`Please refer to your supplemental new drug application (sNDA) dated and received May
`9, 2019, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for SUBSYS (fentanyl sublingual spray).
`
`We also refer to our letter dated April 9, 2019, notifying you, under Section 505(o)(4) of
`the FDCA, of new safety information that we believe should be included in the labeling
`for SUBSYS. This information pertains to storage and disposal of SUBSYS, and risk of
`central sleep apnea. Additionally, the letter included a labeling change request
`regarding an update to labeling for serotonin syndrome.
`
`This supplemental new drug application provides for revisions to the labeling for
`SUBSYS, consistent with our April 9, 2019, letter.
`
`APPROVAL & LABELING
`
`We have completed our review of this supplemental application. 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.1 Content of labeling must be identical to the enclosed labeling, with the
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`Reference ID: 4501156
`
`

`

`NDA 202788/S-020
`Page 2
`
`
`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. To do so, submit the following, in triplicate, (1) a cover letter
`requesting advisory comments, (2) the proposed materials in draft or mock-up form with
`annotated references, and (3) the Prescribing Information to:
`
`
`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`
`Alternatively, you may submit a request for advisory comments electronically in eCTD
`format. For more information about submitting promotional materials in eCTD format,
`see the draft 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
`
`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 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent
`version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4501156
`
`

`

`NDA 202788/S-020
`Page 3
`
`
`[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 For more information
`about submission of promotional materials to the Office of Prescription Drug Promotion
`
`(OPDP), see FDA.gov.6
`
`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) to the
`address above, by fax to 301-847-8444, or electronically in eCTD format. For more
`
`information about submitting promotional materials in eCTD format, see the draft
`guidance for industry Providing Regulatory Submissions in Electronic and Non-
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`Prescription Drugs.
`
`
`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, Safety Regulatory
`
`Project Manager, at (301) 796-2915.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Judith A. Racoosin, MD, MPH
`Deputy Director for Safety
`Division of Anesthesia, Analgesia,
`and Addiction Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE:
` Content of Labeling
`
` Medication Guide
`
`
`
`
`
` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
` 6 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4501156
`
`

`

`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.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`JUDITH A RACOOSIN
`10/07/2019 04:34:08 PM
`
`Reference ID: 4501156
`
`(
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