`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`NDA 022304/S-014
`
`NDA 022304/S-015
`
`
`
`
`
`
`
`Food and Drug Administration
`
`Silver Spring, MD 20993
`
`
`SUPPLEMENT APPROVAL
`
`
`Supplement-14
`Supplement-15
`
`Submitted and received on July 29, 2013
`Submitted and received on September 24, 2013
`
`
`Janssen Research and Development, LLC
` on behalf of Janssen Pharmaceuticals Inc.
`
`920 Route 202 South, P.O. Box 300
`Raritan, NJ 08869-0602
`
`Attention: Tania Hillmer, MS, RAC
`Associate Director, Regulatory Affairs
`
`
`
`Dear Ms. Hillmer:
`
`Please refer to your Supplemental New Drug Applications (sNDAs) submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Nucynta (tapentadol)
`immediate-release tablets:
`
`
`
`
`These “Changes Being Effected” supplemental new drug applications provide for the addition of
`anaphylactic shock and panic attack as adverse reactions listed in section 6 ADVERSE
`
`REACTIONS/6.2 Post-marketing Experience.
`
`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.
`
`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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert), 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.
`
`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
`
`
`Reference ID: 3400040
`
`
`
` NDA 022304/S-014 and S-015
`
`Page 2
`
`
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`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).
`
` 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 Dominic Chiapperino, Ph.D., Senior Regulatory Health Project
`Manager, at (301) 796-1183.
`
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Bob A. Rappaport, M.D.
`
`Director
`
`Division of Anesthesia, Analgesia, and
`Addiction Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE(S):
`Content of Labeling
`
`Reference ID: 3400040
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`BOB A RAPPAPORT
`10/31/2013
`
`Reference ID: 3400040
`
`