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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 203794/S-002, S-003
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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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`Janssen Research and Development, LLC
` on behalf of Janssen Pharmaceuticals Inc.
`
`920 Route 202 South, P.O. Box 300
`Raritan, NJ 08869-0602
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`Attention: Tania Hillmer, MS, RAC
`Associate Director, Regulatory Affairs
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`
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`Dear Ms. Hillmer:
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`Please refer to your Supplemental New Drug Applications (sNDAs) dated and received July 30,
`2013 (S-002), and dated and received September 24, 2013 (S-003), submitted under section
`505(b)) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Nucynta (tapentadol) oral
`solution.
`
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`Supplement S-002 proposes revisions to the package insert intended to harmonize the Nucynta
`oral solution label to the updated labels of other tapentadol products, Nucynta immediate release
`tablets (NDA 022304) and Nucynta ER extended-release tablets (NDA 200533).
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`Supplement S-003 provides for revisions to the ADVERSE REACTIONS: Post-marketing
`Experience section of the package insert. Adverse events, anaphylactic shock and panic attack,
`are added.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications. They are approved, effective
`on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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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 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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, Medication
`Guide, and Instructions for Use), 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.
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`Reference ID: 3658922
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`NDA 203794/S-002, S-003
`Page 2
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
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`
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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 includes 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 MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, 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).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Dominic Chiapperino, PhD, Senior Regulatory Health Project
`Manager, at (301) 796-1183.
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`Sincerely,
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`{See appended electronic signature page}
`
`
`Sharon Hertz, MD
`Acting Director
`Division of Anesthesia, Analgesia, and
`Addiction Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
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`Reference ID: 3658922
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`SHARON H HERTZ
`11/17/2014
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`Reference ID: 3658922
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