`
`Aggraval Package for:
`
`I
`
`‘ APPLICATION NUMBER:
`
`NDA 20-717/5-002
`
`Name:
`
`Provigil Tablets
`
`Generic Name:
`
`modafinil
`
`SponSor:
`
`\
`
`Cephalon', Inc.
`
`V Approval Date: -
`
`5/17/00
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPLICA TION NUMBER:
`
`NDA 20-717/S-002
`
`CONTENTS.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Pharmacoloa 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-002
`
`APPROVAL LETTER
`
`
`
`I,"
`
`'
`
`.
`
`.
`
`l
`
`'
`
`r
`
`' fé DEPARTMENTOFHEALTH&HUMANSERVICES
`
`M W
`
`
`
`Food and Drug Administration
`Rockville MD 20857
`
`MAYI'TZOM
`
`' NDA 20—717/S-002
`
`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 April 4, 2000, received April 5,
`2000., submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Provigil®
`(modafinil) Tablets.
`
`This "Changes Being Effected" supplemental new drug application provides for revision of the
`specifications for modafinil drug substance, Provigil tablet}:
`j and' Provigil Tablets.
`The changes are in the procedures used by the contract manufacturer, E.
`,
`V
`E
`.
`,
`E ‘
`:1. A requirement to determine the chromatographic tailing factor for the
`modafinil peak during HPLC analysis is also added.
`
`21
`
`:l
`
`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.3l4.8l.
`'
`
`If you have any questions, call Anna Marie HomOnnay, R.Ph., Project Manager", at (301)
`594-2850.
`
`Sincerely,
`'
`
`V
`
`' 00/?”
`
`.
`
`:
`
`[Mary] Guzew , h.D.
`Chemistry Team Leader, Neurology Drugs for the
`Division of Neuropharmacological Drug Products,
`(HFD-120)
`'
`.
`DNDC '1, Office of New Drug Chemistry
`Center for Drug Evaluation and Research
`
`
`
`
`
`NDA 20-717/S—002
`
`Page 2
`
`cc:
`Archival NDA 20—717
`HFD- 120/Div. Files
`
`4?;
`HFD-120/A.Homonnay
`,:
`HFD120/M.Gu'zewska
`I-IFD-120/M.Heimann mifl/
`' HFD-095/DDMS-IMT
`HFD-810/J.Simmons
`DISTRICT OFFICE
`
`'
`
`7/00
`(If 7%,?)
`5/’
`
`Drafted by: mrh/May 17, 2000
`Initialed by:
`final. 5/17/2000
`filename: D:\WORD#WP\#NDA\N20-717\S20717_002_LET.DOC
`
`APPROVAL (AP)
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPLICA TION NUMBER:
`
`_
`
`NDA 20-717/S-002 '
`
`CHEMISTRY REVIEWQ S [I
`
`
`
`CHEMIST'S REVIEW
`
`OF SUPPLEMENT
`
`ORGANIZATION:
`
`NDA NUMBER:
`
`SUPPLEMENT N UMBER:
`LETTER DATE
`STAMP DATE
`
`AMENDMENTS/REPORTS:
`LETTER DATE
`STAMP DATE
`
`RECEIVED BY CHEMIST:
`
`\
`
`H FD-1 20
`
`20-717
`
`SCM-OOZ
`04-APR-2000
`05-APR-2000
`
`N/A
`N/A
`
`13-APR-2000
`
`Applicant Name and Address:
`
`Cephalon, Inc.
`145 Brandywine Parkway
`West Chester, PA 19380-4245
`
`NAME OF DRUG:
`
`NONPROPRIETARY NAME:
`
`PROVIGIL®
`
`Modafinil
`
`CHEMICAL NAME I STRUCTURE:
`DOSAGE FORM (3):
`POTENCY(IES):
`
`PHARMACOLOGICAL CATEGORY:
`
`2-[(Diphenylmethyl)suIfinyllacetamide
`Tablet
`100 mg, 200 mg
`
`Narcolepsy
`
`o
`O I?
`\)I\Npq
`
`0
`
`How DISPENSED:
`
`XX (Rx)
`
`RECORDS I REPORTS CURRENT:
`
`XX (YES)
`
`RELATED IND I NDAI DMF(s):
`
`N/A
`
`OTC
`
`(NO)
`
`SUPPLEMENT PROVIDES FOR: revision of the specifications for modafinil drug substance, Provigil tabletE
`I:
`II and Provigil Tablets. The changes are in the procedures used by the contract manufacturer,E
`j
`‘E
`:1 A requirement to determine the chromatographic tailing factor for the modafinil peak 2
`
`:1
`
`during HPLC analysis is also added.
`
`COMMENTS: The changes below apply to all HPLC procedures for analysis of bulk drug substance
`(assay/related substances), the E
`j and finished tablets
`(assay/related substances andE
`.
`
`:1) except as noted.
`
`_
`
`CONCLUSIONS AND RECOMMENDATIONS:
`
`Recommend Approval of 8-001.
`
`cc: Orig. NDA 20-717
`HFD-120/Divisi0n File
`
`HFD-120/AHommonay
`HFD—120/MGuzewska/lnit.by: MG/
`HFD-120/MHeimann
`
`Filename: D:\WORD#WP\#NDA\N20-717\820717_002.DOC
`
`Review Completed: 17-MAY-2000
`
`Martha R. Heimann, Ph.D., Review Chemist
`
`
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