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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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`
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`NDA 21-976/S-012
`NDA 21-976/S-013
`
`
`Tibotec Incorporated
`Attention: Susan Fiordeliso
`Manager, Global Regulatory Affairs
`1020 Stony Hill Road, Suite 300
`Yardley, PA 19067
`
`Dear Ms Fiordeliso:
`
`Please refer to your supplemental new drug applications dated and received March 27, 2009,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`PREZISTA® (darunavir) tablets:
`
`
`Supplement Study
`Application
`
`NDA 21-976 S-012
`TMC114-C214
`NDA 21-976 S-013
`TMC114-C211
`
`
`We acknowledge receipt of your submissions dated July 14, 2009, July 17, 2009, August 26,
`2009, September 16, 2009, September 28, 2009, January 15, 2010 and January 26, 2010.
`
`These Prior Approval supplemental new drug applications provide for updates to the U.S.
`Package Insert and Patient Package Insert with 96 week data from two trials, one in treatment-
`experienced patients and one in treatment-naive patients to support the use of PREZISTA®
`
`(darunavir) tablets for the treatment of HIV-1 infection.
`
`We have completed our review of this application, as amended. It is 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, please submit the
`content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format as
`described at http://www.fda.gov/oc/datacouncil/spl.html that is identical to the enclosed
`labeling (text for the package insert, text for the patient package insert). For administrative
`purposes, please designate this submission, “SPL for approved NDA 21-976/S-012 and NDA
`21-976/S-013”.
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` NDA 21-976/S-012
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` NDA 21-976/S-013
`Page 2
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` LABELING
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`The final printed labeling (FPL) must be identical to the enclosed labeling (text for the package insert
`and text for the patient package insert).
`
`
` PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert(s)
`to:
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`
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert(s), at the time of initial dissemination or publication, accompanied by a Form
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`FDA 2253. For instruction on completing the Form FDA 2253, see page 2 of the Form. For
`more information about submission of promotional materials to the Division of Drug Marketing,
`Advertising, and Communications (DDMAC), see
`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
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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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`
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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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`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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` NDA 21-976/S-012
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` NDA 21-976/S-013
`Page 3
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`If you have any questions, call Stacy Powers Newalu, M.P.H., Regulatory Project Manager, at
`(301) 796-3978.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Debra Birnkrant, M.D.
`Director
`
`Division of Antiviral Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`Enclosure
`Content of Labeling
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`Application
`Type/Number
`--------------------
`NDA-21976
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`Submission
`Type/Number
`--------------------
`SUPPL-13
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`NDA-21976
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`SUPPL-12
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`Submitter Name
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`Product Name
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`--------------------
`CENTOCOR
`ORTHO BIOTECH
`INC
`CENTOCOR
`ORTHO BIOTECH
`INC
`
`------------------------------------------
`PREZISTA
`
`PREZISTA
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JEFFREY S MURRAY
`01/27/2010
`
`
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