`
`Aggraval Package for:
`
`APPLICA TION NUMBER:
`NDA 20-717/S-001
`
`Name:
`
`Provigil Tablets
`
`Generic Name:
`
`} modafinil
`
`Sponsor:
`
`‘
`
`Cephalon, Inc.
`
`Approval Date:
`
`.
`
`12/14/99.
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH "
`
`APPLICA TION NUMBER:
`
`NDA 20-717/S-001
`
`CONTENTS
`
`
`
`
`
`A roval Letter
`
`.
`
`A n 7: rovable Letter s
`Final Printed Labelin_
`
`
`
`
`
`Medical Review s
`
`Chemist Review s
`
`Pharmacolo_ Review 's
`Statistical Review s
`
`Microbiolo_ Review s
`Clinical Pharmac0103 [Bio n harmaceutics Review s
`Administrative and Corres ondence Document(s
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPLICA TI0N NUMBER:
`
`NDA 20—717/5—001 .
`
`APPROVAL LETTER
`
`
`
`
`
`Food and Drug Administration
`Rockville MD 20857
`
`NDA 20—717/S-001
`
`Cephalon, Inc.
`Attention: Paul M Kirsch
`
`Director, U.S. Regulatory Operations
`145 Brandywine Parkway
`West Chester, PA 19380—4245
`
`Dear Mr. Kirsch:
`
`Please refer to your supplemental new drug application dated November 16, 1999, received
`November 17, 1999, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`Act for Provigi1® (modafinil) Tablets.
`
`:1
`The supplemental application provides for revision of the specification forl:
`(magnesium silicate) used in the manufacture of Provigil Tablets by widening the limits for Loss
`on Drying (LOD) and Loss on Ignition (LOI).
`
`We have completed the review of this supplemental application and it is approved.
`
`We remind you that you must comply with the requirements for an approved NDA set forth
`under 21 CFR 314.80 and 314.81.
`
`If you have any questions, contact Anna Marie Homonnay-Weikel, R.Ph., Project Manager, at
`(301) 594—5535.
`
`Sincerely,
`
`Maryla Guzewska, Ph.D.
`Chemistry Team Leader, Neurology Drugs for the
`Division of Neuropharrnacological Drug Products,
`(HFD—120)
`DNDC I, Office of New Drug Chemistry
`Center for Drug Evaluation and Research
`
`
`
`NDA 20-717/S-003
`
`Page 2
`
`cc:
`
`Archival NDA 20—7 1 7
`
`HFD- l 20/division file
`
`HFD— 1 20/A.Hommonay- Weikel
`HFD— 120/M.Guzewska
`HFD- l 20/M.Heimann
`HFD—O95/DDMS—IMT
`
`HFD—8 l O/DNDC Division Director/JSimmons
`DISTRICT OFFICE
`
`Drafted by: MRH/December 13, 1999
`Initialed by: M.Guzewska
`Final: MRH/12/14/99
`
`filenamc: D:\WORD#WP\#NDA\N20—7l7\SZO717__001_LET.DOC
`
`APPROVAL (AP)
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPLICATION NUMBER:
`
`NDA 20-717/S-001
`
`CHEMISTRY REVIEWg S!
`
`
`
`CHEMIST'S REVIEW
`
`OF SUPPLEMENT
`
`ORGANIZATION:
`
`NDA NUMBER:
`
`SUPPLEMENT NUMBER:
`LETTER DATE
`STAMP DATE
`
`AMENDMENTS/REPORTS:
`LETTER DATE
`STAMP DATE
`
`RECEIVED BY CHEMIST:
`
`HFD-120
`
`20-717
`
`SCS-001
`16-NOV-1999
`17-NOV-1999
`
`N/A
`N/A
`
`23-Nov-1999
`
`Applicant Name and Address:
`
`Cephalon, Inc.
`145 Brandywine Parkway
`West Chester, PA 19380-4245
`
`NAME OF DRUG:
`
`NONPROPRIETARY N AME:
`
`PROVIGIL®
`
`Modafinil
`
`CHEMICAL NAME I STRUCTURE:
`
`DOSAGE FORM (6):
`
`2-[(Diphenylmethyl)sulfinyl]acetamide
`Tablet
`
`POTENCY(IEs):
`PHARMACOLOGICAL CATEGORY:
`
`100 mg, 200 mg
`
`Narcolepsy
`
`How DISPENSED:
`
`RECORDS I REPORTS CURRENT:
`
`RELATED IND 1 NBA] DMF(s):
`
`XX (Rx)
`
`XX (YESi
`N/A
`
`OTC
`
`1N0)
`
`:1 (magnesium silicate) used in the
`SUPPLEMENT PROVIDES FOR: revision of the specification for E:
`manufacture of Provigil Tablets by widening the limits for Loss on Drying (LOD) and Loss on ignition (LOl).
`
`COMMENTS; l:
`
`:1
`
`:1 The type of supporting data required was discussedIn a
`"I:
`telecon with the sponsor on 16-SEP-99 All of the supporting information that we requested has been
`providedIn this submission. [Refer to review notes. ]
`
`CONCLUSIONS AND RECOMMENDATIONS 1
`
`Recommend Approval of 8-001.
`
`cc: Orig. NDA 20—717
`HFD-120/Division File
`HFD-120/AHommonay-Weikel
`HFD-120/MGuzewska/lnit.by: MG/
`HFD-120/MHeimann
`
`Filename: D:\WORD#WP\#NDA\N20-717\820717_001.DOC
`
`Review Completed: 14-DEC-1999
`
`Martha R. Heimann, Ph.D., Review Chemist
`
`
`
` Redacted .' 2 +
`
`page(s)
`
`_
`
`of trade secret and/or
`
`J confidential , commercial
`
`' information from ‘
`
`
`
`
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