`
`
`
` DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`
`
`
`
`
`Public Health Service
`
`Food and Drug Administration
`
`Rockville, MD 20857
`
`
`
`
`
`
`
`
`NDA 21-976/S-011
`
`
`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 application dated February 27, 2009, received February 27,
`2009, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for PREZISTA®
`(darunavir) tablets.
`
`This “Changes Being Effected” supplemental new drug application provides for revision to the U.S.
`Package Insert and Patient Package Insert to include 150 mg tablets.
`
`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.
`
`The final printed labeling (FPL) must be identical to the enclosed labeling (text for the package insert,
`patient package insert, and immediate container label).
`
`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.
`
`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:
`
`
`
`
`
`MEDWATCH
`
`Food and Drug Administration
`Suite 12B05
`
`5600 Fishers Lane
`
`Rockville, MD 20857
`
`
`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
`314.80 and 314.81).
`
`
`
`
`
`
`
`
`
`
`
`
`NDA 21-976/S-011
`Page 2
`
`If you have questions, call Stacy 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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Enclosure: package insert, patient package insert, and immediate container label
`
`
`
`
`
`
`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
`/s/
`
`---------------------
`Kendall Marcus
`
`6/15/2009 03:13:16 PM
`
`
`