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` DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
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`Food and Drug Administration
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`Rockville, MD 20857
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`NDA 21-976/S-010
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`Tibotec, Incorporated
`Attention: Susan Fiordeliso
`Manager, Global Regulatory Affairs
`1020 Stony Hill Road, Suite 300
`Yardley, PA 19067
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`Dear Ms. Fiordeliso:
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`Please refer to your supplemental new drug application dated and received December 15, 2008,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for PREZISTA®
`(darunavir) Tablets.
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`We acknowledge receipt of your submissions dated January 9, 2009, January 30, 2009, April 3, 2009,
`April 14, 2009, and April 23, 2009.
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`This supplemental new drug application provides for revisions to the DRUG INTERACTIONS and
`CLINICAL PHARMACOLOGY sections of the package insert to include results from a drug-drug
`interaction study between darunavir/ritonavir twice daily and buprenorphine/naloxone. In addition, the
`results of this drug-drug interaction study were added to the “CAN PREZISTA BE TAKEN WITH
`OTHER MEDICATIONS?” section of the patient package insert.
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`We completed our review of this application, as amended. This application is approved, effective on
`the date of this letter, for use as recommended in the agreed-upon labeling text.
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`Approval of this supplement fulfills the following postmarketing commitment number acknowledged
`in our June 23, 2006, approval letter:
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`6.
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` Conduct an in vivo drug interaction study between darunavir/rtv bid and
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` buprenorphine/naloxone.
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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(1)] 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 and patient package insert). 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-010.”
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`The final printed labeling (FPL) must be identical to the enclosed labeling (text for the package insert
`and patient package insert).
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`NDA21-976/S-010
`Page 2
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`In addition, within 21 days of the date of this letter, amend any pending applications for this NDA with
`content of labeling in structured product labeling (SPL) format to include the changes approved in this
`application.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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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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`MEDWATCH
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`Food and Drug Administration
`Suite 12B05
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`5600 Fishers Lane
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`Rockville, MD 20857
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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 Stacy Powers Newalu, M.P.H., Regulatory Project Manager, at (301)
`796-3978.
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`Enclosure (package insert, patient package insert)
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`Sincerely,
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`{See appended electronic signature page}
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` M.D.
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` Birnkrant,
`Debra
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`Director
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`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.
`---------------------------------------------------------------------------------------------------------------------
`/s/
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`---------------------
`Kendall Marcus
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`6/15/2009 05:01:20 PM
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