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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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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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`NDA 022304/S-001
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`Ortho-McNeil-Janssen Pharmaceuticals, Inc.
`c/o Johnson & Johnson Pharmaceutical Research
` & Development, L.L.C.
`1125 Trenton-Harbourton Road
`P.O. Box 200
`Titusville, NJ 08560-0200
`
`Attention: Kathleen F. Dusek, R.Ph., RAC
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` Associate Director, Regulatory Affairs
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`Dear Ms. Dusek:
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`Please refer to your supplemental new drug application dated June 22, 2009, received June 22,
`2009, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Nucynta (tapentadol) immediate-release oral tablets.
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`This supplemental new drug application provides for the addition of C-II symbol and text for
`controlled substances. Additionally, your proprietary name “NUCYNTA” is incorporated into
`the package insert, medication guide and carton and container 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 text, which is identical to
`the content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format
`submitted on June 22, 2009.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`We also acknowledge that your June 22, 2009, submission contained final printed carton and
`container labels.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you 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 an electronic copy of
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`the letter to both this NDA and to the following address:
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`MedWatch
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`Food and Drug Administration
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`5600 Fishers Lane, Room 12B05
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`Rockville, MD 20857
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`NDA 022304/S-001
`Page 2
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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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`Bob A. Rappaport, M.D.
`Director
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`Division of Anesthesia, Analgesia, and
` Rheumatology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`Enclosures
`Content of Labeling
`Carton and Container Labeling
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`Application
`Type/Number
`--------------------
`NDA-22304
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`Submission
`Type/Number
`--------------------
`SUPPL-1
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`Submitter Name
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`Product Name
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`--------------------
`ORTHO MCNEIL
`JANSSEN
`PHARMACEUTICA
`LS INC
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`------------------------------------------
`NUCYNTA
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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/
`----------------------------------------------------
`
`BOB A RAPPAPORT
`11/09/2009
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`