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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-001
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`Tibotec, Inc.
`Attention: Jenny Z. Lin, PharmD
`Manager, Global Regulatory Affairs
`1020 Stony Hill Road, Suite 300
`Yardley, PA 19067
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`Dear Dr. Lin:
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`Please refer to your supplemental new drug application dated October 31, 2006, received November 1,
`2006, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for PREZISTA™
`(darunavir) Tablets.
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`This “Changes Being Effected” supplemental new drug application provides for a revision to the
`INDICATIONS AND USAGE, Description of Clinical Studies, Treatment-Experienced Subjects,
`Studies TMC114-C213 and TMC114-C202 section of the Package Insert (PI). The following sentence
`was changed from “Selected PI(s) in the control arm included: lopinavir/ritonavir in 36%,
`(fos)amprenavir in 34%, saquinavir in 35% and atazanavir in 17%; 23% of the control subjects used
`dual-boosted PIs” to “Selected PI(s) in the control arm included: lopinavir in 36%, (fos)amprenavir in
`34%, saquinavir in 35% and atazanavir in 17%; 98% of control subjects received a ritonavir boosted PI
`regimen out of which 23% of control subjects used dual-boosted PIs.” These changes were requested
`in order to furnish adequate information for the safe and effective use of the drug.
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`We completed our review of this supplemental new drug application and it is approved, effective on
`the date of this letter, for use as recommended in the final printed labeling (FPL) submitted on October
`31, 2006.
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
`Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to
`the following address:
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`We remind you that you must comply with the requirements for an approved NDA set forth under
`21 CFR 314.80 and 314.81.
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`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
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`NDA 21-976/S-001
`Page 2
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`If you have any questions, call Elizabeth Thompson, M.S., Regulatory Project Manager, at (301) 796-
`0824.
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`Sincerely,
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`{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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`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
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` /s/
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`Debra Birnkrant
`11/20/2006 11:01:17 AM
`NDA 21-976
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