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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDA 21-976/S-005
`
`Tibotec, Inc.
`Jenny Z. Lin, Pharm.D.
`Attention:
`Sr. Manager, Global Regulatory Affairs
`
`
`1020 Stony Hill Road, Suite 300
`Yardley, PA 19067
`
`
`Dear Ms. Lin:
`
`Please refer to your supplemental new drug application (sNDA) dated October 23, 2007,
`received October 25, 2007, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act for PREZISTA (darunavir) Tablets.
`
`We acknowledge receipt of your amendments dated December 14, 2007, and February 15, 2008.
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`This new drug application provides for the addition of a new 600 mg tablet strength for
`darunavir.
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`We have completed our review of this application. It is approved, effective on the date of this
`letter, for use as recommended in the agreed upon draft content of labeling submitted on
`February 25, 2008.
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`CONTENT OF LABELING
`
`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)] in structured product labeling (SPL) format as described
`at http://www.fda.gov/oc/datacouncil/spl.html that is identical to the enclosed labeling. Upon
`receipt, we will transmit that version to the National Library of Medicine for public
`dissemination. For administrative purposes, please designate this submission “SPL for approved
`NDA 21-976/S-005.”
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`We acknowledge your October 23, 2007 submission containing final printed carton and
`container labels. Submit final printed carton and container labels that are identical to the
`submitted carton and immediate container labels as soon as they are available, but no more than
`30 days after they are printed. Please submit these labels electronically according to the guidance
`for industry titled Providing Regulatory Submissions in Electronic Format – Human
`Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
`(October 2005). Alternatively, you may submit 12 paper copies, with 6 of the copies
`individually mounted on heavy-weight paper or similar material. For administrative purposes,
`designate this submission “Final Printed Carton and Container Labels for approved NDA
`
`

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`NDA 21-976/S-005
`Page 2
`
`21-976/S-005.” Approval of this submission by FDA is not required before the labeling is used.
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`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
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`POSTMARKETING COMMITMENTS
`
`We remind you of your postmarketing study commitment in your submission, sent via email,
`dated February 25, 2008. This commitment is listed below.
`
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`1. Revise the debossment on the 600mg tablet to make it meet the requirements of a unique
`identifier.
`
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`Proposal Submission: March 3, 2008
`
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`Submit nonclinical and chemistry, manufacturing, and controls protocols and all study final
`reports to this NDA. In addition, under 21 CFR 314.81(b)(2)(vii) and 314.81(b)(2)(viii), you
`should include a status summary of each commitment in your annual report to this NDA. The
`status summary should include expected summary completion and final report submission dates,
`any changes in plans since the last annual report, and, for clinical studies, number of patients
`entered into each study. All submissions, including supplements, relating to these postmarketing
`study commitments should be prominently labeled “Postmarketing Study Commitment
`Protocol”, “Postmarketing Study Commitment Final Report”, or “Postmarketing Study
`Commitment Correspondence.”
`
`We remind you that you must comply with the reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Rebecca McKnight, Regulatory Health Project Manager, at
`(301) 796-1765.
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`Sincerely,
`
`{See appended electronic signature page}
`
`Eric P. Duffy, Ph.D.
`Director
`Office of New Drug Quality Assessment
`Center for Drug Evaluation and Research
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`Enclosure: Draft Content of Labeling
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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/
`---------------------
`Eric Duffy
`2/25/2008 05:12:19 PM
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`