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` NDA 021926/S-017/S-018
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` Currax Pharmaceuticals LLC
` Attention: Joyce Fan
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` Vice President, Associate General Counsel
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` 10 North Park Place, Suite 201
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` Morristown, NJ 07960
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`Dear Ms. Fan:
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`Please refer to your supplemental new drug applications (sNDAs) dated and received
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`June 28, 2019 (S-017), and November 12, 2020 (S-018), and your amendments,
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`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
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`for Treximet (sumatriptan and naproxen sodium) tablets.
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`Prior Approval supplemental new drug application S-017 provides for revisions to the
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`labeling for Treximet to comply with the Pregnancy and Lactation Labeling Rule (PLLR).
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`We also refer to our letter dated October 15, 2020, notifying you, under Section
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`505(o)(4) of the FDCA, of new safety information that we believe should be included in
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`the labeling for nonsteroidal anti-inflammatory drug (NSAID) products. This information
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`pertains to the serious risks of fetal renal dysfunction, oligohydramnios, and neonatal
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`renal impairment, and Drug Reaction with Eosinophilia and Systemic Symptoms
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`(DRESS).
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`Supplemental new drug application S-018 provides for revisions to the labeling for
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`Treximet consistent with our October 15, 2020, letter.
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`APPROVAL & LABELING
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` We have completed our review of these applications, as amended. They are approved,
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` effective on the date of this letter, for use as recommended in the enclosed agreed-
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` upon labeling.
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` SUPPLEMENT APPROVAL
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`Reference ID: 4785360
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` NDA 021926/S-017/S-018
` 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
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information and Medication Guide), with the addition of any labeling
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`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`reportable changes 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 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
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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 these supplemental applications, as well
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`as annual reportable changes. To facilitate review of your submission(s), provide a
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`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
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`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
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`promotional labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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` 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
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` https://www.fda.gov/media/128163/download.
`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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` www.fda.gov
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`Reference ID: 4785360
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` NDA 021926/S-017/S-018
` Page 3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[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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`All promotional materials that include representations about your drug product must be
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`promptly revised to be consistent with the labeling changes approved in these
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`supplements, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
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`in your promotional materials should include prominent disclosure of the important new
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`safety information that appears in the revised labeling. Within 7 days of receipt of this
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`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
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, contact Alina Salvatore, Senior Regulatory Project Manager,
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`at alina.salvatore@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Alice T.D. Hughes, MD
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`Deputy Director for Safety
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`Division of Neurology 2
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`Office of Neuroscience
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`Center for Drug Evaluation and Research
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`ENCLOSURE:
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`• Content of Labeling
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`o Prescribing Information
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`o Medication Guide
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`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
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` www.fda.gov
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`Reference ID: 4785360
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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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`ALICE HUGHES
`04/28/2021 09:32:07 AM
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`Reference ID: 4785360
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`(
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