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`Food and Drug Administration
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`Silver Spring, MD 20993
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 022304/S-003
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` NDA 022304/S-004
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`Reference ID: 2858116
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` SUPPLEMENT APPROVAL
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`Ortho-McNeil-Janssen Pharmaceuticals, Inc.
`c/o Johnson & Johnson Pharmaceutical Research
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`& Development, L.L.C.
`1125 Trenton-Harbourton Road, P.O. Box 200
`Titusville, NJ 08560-0200
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`Attention: Kathleen F. Dusek, R.Ph., RAC
`Associate Director, Regulatory Affairs
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`Dear Ms. Dusek:
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`Please refer to your Supplemental New Drug Applications dated March 10 and June 21, 2010,
`received March 10 and June 22, 2010, (Supplement 003 and 004, respectively) and submitted
`under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Nucynta
`
` (tapentadol).
`
`These “Changes Being Effected” supplemental new drug applications provide for the addition of
`two post-marketing adverse events (hallucinations and headache). We also note that your
`submissions included the Medication Guide, which remains unchanged from our November 9,
`2009, letter approving Supplement 001.
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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, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling text for the package insert and include the labeling changes
`proposed in any pending “Changes Being Effected” (CBE) supplements. Information on
`submitting SPL files using eLIST may be found in the guidance for industry titled “SPL
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`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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` NDA 022304/S-003
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` NDA 022304/S-004
`Page 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 for this NDA, including
`pending “Changes Being Effected” (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.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA to the following
`address:
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`MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administration
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`10903 New Hampshire Ave
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`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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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 Matt Sullivan, Regulatory Project Manager, at 301-796-1245.
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`Sincerely,
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`{See appended electronic signature page}
`
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`Sharon Hertz, M.D.
`Deputy Director
`Division of Anesthesia and Analgesia 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: 2858116
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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
`11/01/2010
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`Reference ID: 2858116
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