`
` NDA 204592/S-013
`
`
`
`Zyla Life Science US, Inc.
`C/O Assertio Therapeutics, Inc.
`
`100 S. Saunders Road
`Suite 300
`Lake Forest, IL 60045
`
`
`Attention:
`
`Clorey Toombs, RAC
`Senior Director, Regulatory Affairs
`
`SUPPLEMENT APPROVAL
`
`
`
`
`Dear Ms. Toombs:
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`November 20, 2020, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Zorvolex (diclofenac) capsules.
`
`We also refer to our letter dated October 15, 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 nonsteroidal anti-inflammatory drug (NSAID) products. This information
`pertains to the serious risks of fetal renal dysfunction, oligohydramnios, and neonatal
`renal impairment, and Drug Reaction with Eosinophillia and Systemic Symptoms
`(DRESS).
`
`This supplemental new drug application provides for revisions to the labeling for
`Zorvolex consistent with our October 15, 2020, letter.
`
`
`APPROVAL & LABELING
`
`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.
`
`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: 4786646
`
`

`

`NDA 204592/S-013
`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. 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
`
`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).
`
`
`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: 4786646
`
`

`

`
`
`Sincerely,
`
` {See appended electronic signature page}
`
`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
`
`NDA 204592/S-013
`Page 3
`
`
`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.
`
`
`
`ENCLOSURE:
`
` Content of Labeling
`o Prescribing Information
`
`o Medication Guide
`
`
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4786646
`
`

`

`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/
`------------------------------------------------------------
`
`MARK A LIBERATORE
`04/28/2021 09:37:22 AM
`
`Reference ID: 4786646
`
`(
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