`
`Approval Package for:
`
`APPLICA TION NUMBER:
`
`NDA 20-717/S-003
`
`Name:
`
`.
`
`' Provigil Tablets
`
`Generic Name:
`
`modafinil
`
`Sponsor
`
`Cephalon, Inc.
`
`Approval Date:
`
`09/ 1 9/00
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPLICA TION NUMBER:
`
`NDA 20-717/S-003
`
`CONTENTS
`
`
`
`
`
`
`
`Reviews / Information Included in this ReviewL j
`
`A roval Letter
`
`A in rovable Letter s
`Final Printed Labelin_
`
`
`
`
`
`Medical Review s
`
`Chemist Review s
`
`Pharmacolog Review s
`Statistical Review s
`
`Microbiolo$ Review s
`Clinical Pharmacolo 3 [Bio n harmaceutics Review s
`Administrative and Corres ondence Document s
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPLICA TION NUMBER:
`
`NDA 20-717/S-003
`
`APPROVAL LETTER
`
`
`
`SEP _l 9 2000
`
`NDA 20—717/8—003
`
`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 August 15, 2000, received
`August 16, 2000, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act for PROVIGIL® (modafinil) Tablets 100 mg and 200 mg.
`
`We acknowledge receipt of your submission dated August 15, 2000, received
`September 15, 2000.
`
`This “Changes Being Effected" supplemental new drug application provides for a
`revision of the specifications and procedures for the drug product. Provigil.
`
`We have completed the review of this supplemental new drug application, as amended,
`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, call Anna Marie Homonnay, R.Ph., Regulatory Management
`Officer, at (301 ) 594—2850.
`
`Sincerely,
`
`'
`
`IQ/
`
`/
`
`Q/H/Qo
`
`h.D.
`uzews ',
`Maryla
`Chemistry Team Leader, Neurology Drugs for the Division
`of Neuropharmocological Drug Products, (HFD—120)
`DNDC l. Office of New Drug Chemistry
`Center for Drug Evaluation and Research
`
`
`
`cc:
`
`Archival NDA 20-717
`HFD-120/Div. Files
`HFD-120/AMHommona
`
`'
`
`HFD-1zo/DJCummingsigL/‘I/H/‘N’Q‘3
`
`HFD—120/MGuzewska
`HFD-120/MHeimann
`H FD—OQS/DDMS—IMT
`H FD-81 0/JSimmons
`DISTRICT OFFICE
`
`Drafted by: DJCISeptember 19, 2000
`lnitialed by:
`Final:
`Filename: N2071783.APL
`
`APPROVAL (AP)
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPLICA TION NUMBER:
`
`NDA 20-717/S-003
`
`CHEMISTRY REVIEW(S)
`
`
`
`CHEMIST'S REVIEW
`OF SUPPLEMENT
`
`ORGAN'ZAT'OM
`NDA NUMBER.
`SUPPLEMENT N UMBER:
`LETTER DATE
`STAMP DATE
`AMENDMENTS/REPORTS:
`LETTER DATE
`STAMP DATE
`RECEIVED BY CHEMIST:
`
`APPLICANT NAME AND ADDRESS:
`
`CEPHALON
`
`West Chester, PA 19380-4245
`
`145 Brandywine Parkway
`
`NAME OF DRUG:
`NONPROPRIETARY NAME:
`
`PROVIGILO
`Modafinil
`
`HFD-120
`20'717
`SCS-003
`15-AUG-00
`16-AUG-00
`
`15-AUG-00
`15-SEP-00
`06-SEP-00
`
`o
`
`o
`
`”\A
`
`8
`
`W2
`
`CHEMICAL NAME I STRUCTURE:
`DOSAGE FORM (5):
`POTENCY(IES):
`PHARMACOLOGICAL CATEGORY:
`
`How DISPENSED:
`RECORDS / REPORTS CURRENT:
`RELATED IND I NDA I DMF(s):
`
`2-[(Diphenylmethyl)sulfinyl]acetamide
`Tablet (oral)
`100 mg and 200 mg
`To improve wakefulness in patients with excessive daytime sleepiness
`associated with narcolepsy.
`XX (Rx)
`XX (YES)
`N/A
`
`SUPPLEMENT PROVIDES FOR: Revision of the specifications and procedures for the drug product, Provigil
`(CBE-30).
`
`COMMENTS:
`
`The firm provides copies of the revised specifications and methods (release and stability) for
`the 100 mg and 200 mg tablets. The references to USP 23 are changed to USP 24. The firm
`has implemented other minor Changes. A copy of the revised cover letter is provided in
`Attachment 1.
`
`CONCLUSIONS AND RECOMMENDATIONS: APPROVAL
`
`REVIEWER NAME
`
`SIGNATURE
`
`DATE COMPLETED
`
`David J. Cummings
`
`cc: Orig.; NDA 20-717
`HFD-120/Div. File
`
`HFD-120/AHommonay
`HFD-120/DJCummings
`HFD-120/MHeimann
`INIT: MGuzewska/
`
`September 19, 2000
`
`Filename: N20717S3
`
`
`
`Redacted ‘
`
`é
`
`page(s)
`
`.
`
`of trade secret and/or ,
`
`~
`
`1
`
` confidential commercial
`
`information from
`
`'
`
`
`
`
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