`
`Public Health Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 20-717/S-006
`
`Cephalon, Inc.
`Attention: Kenneth L. White, Pharm.D.
`Vice President, Regulatory Affairs
`145 Brandywine Parkway
`West Chester, PA 19380-4245
`
`Dear Dr. White:
`
`Please refer to your supplemental new drug application dated March 21,2003, received March 24,2003, submitted under
`section 505(b) of the Federal Food, Drug, and Cosmetic Act for Provigil (modafinil), 100 and 200 mg tablets.
`
`We acknowledge receipt of your submission dated March 21, 2003.
`
`Your submission of March 21, 2003 constituted a complete response to our February 21, 2003 action letter.
`
`This supplemental new drug application provides for revision of the blister unit and carton labeling.
`
`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 submitted labeling (immediate container and carton labels
`submitted March 21, 2003).
`
`Please submit the FPL electronically according to the guidance for industry titled Providing Regulatory Submissions in
`Electronic Format – NDA. Alternatively, you may submit 20 paper copies of the FPL as soon as it is available, in no case
`more than 30 days after it is printed. Please individually mount ten of the copies on heavy-weight paper or similar material.
`For administrative purposes, this submission should be designated "FPL for approved supplement NDA 20717/s-006.”
`Approval of this submission by FDA is not required before the labeling is used.
`
`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, HF-2
`FDA
`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 20-717/S-006
`Page 2
`
`If you have any questions, call Anna Homonnay, Regulatory Project Manager, at (301) 594-5535.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Maryla Guzewska, Ph.D.
`Chemistry Team Leader, Neurology Drugs for the
`Division of Neuropharmacological Drug Products,
`(HFD-120)
`DNDC I, Office of New Drug Chemistry
`Center for Drug Evaluation and Research
`
`
`
`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Maryla Guzewska
`4/16/03 07:21:04 AM
`
`
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