`
`Public Health Service
`
`
`
`
`
`
`
`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 20-717/S-009
`
`Cephalon, Inc.
`Attention: Paul Kirsch
`Senior Director, Regulatory Affairs
`145 Brandywine Parkway
`West Chester, PA 19380-4245
`
`Dear Mr. Kirsch:
`
`Please refer to your Supplemental New Drug Application submitted on March 28, 2003, under
`section 505(b) of the Federal Food, Drug, and Cosmetic Act for Provigil (modafinil) Tablets.
`
`This supplement provides for a new formulation of the drug product, manufacturing changes,
`and the addition of a new site, (b)(4)-------- for manufacturing, testing, packaging and labeling of
`the reformulated drug product.-
`
`We acknowledge receipt of your amendments dated June 13, 17 and 18, 2003.
`
`We have completed our review of this supplement and the application is approved.
`
`We also wish to forward the following additional advice for future submissions:
`
`
`1. Please note that the dissolution test should only use one tablet per vessel rather than
`(b)( to allow for the evaluation of the quality of each tablet.
`
`
`2. In the future, the highest tablet strength, rather than the highest dose, should be used
`in bioequivalence studies.
`
`
`If you should have any questions, please call Ms. Anna Marie H. Weikel, Senior Regulatory
`Health Project Manager, at (301) 594-5535.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Russell Katz, M.D.
`Director
`Division of Neuropharmacological Drug Products
`Office of Drug Evaluation I
`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/
`---------------------
`Thomas Laughren
`7/29/03 07:54:02 AM
`Signed for Russell Katz, M.D.
`
`
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