`C_________’__________—————
`
`Approval Package for:
`
`Application Number: 020717
`
`Trade Name: PROVIGIL TABLETS
`
`Generic Name: MODAFINIL
`
`Sponsor: CEPHALON, INC
`
`Approval Date: 12/24/98
`
`INDICATIONQ s ): TREATMENT OF NARCOLEPSY
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPLICATION: 020717
`
`CONTENTS
`
`
`
`Included
`
`Pending
`Completion
`
`Not
`Not
`Prepared Required
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`X
`
`><><><><><><
`
`>4
`
`Approval Letter
`Tenative Approval Letter
`Approvable Letter
`
`Final Printed Labeling
`
`Medical Review(s)
`
`Chemistry Review(s)
`
`EA/FONSI
`
`Pharmacology Review(s)
`
`Statistical Review(s)
`Microbiology Review(s)
`
`Clinical Pharmacology
`Biopharmaceutics Review(s)
`Bioequivalence Review(s)
`Administrative/
`
`Correspondence Document(s)
`
`X
`X
`
`X
`
`X
`
`.
`
`-
`
`I
`
`'
`
`-'
`
`_,
`
`v"
`
`.
`
`'
`
`,
`
`,
`
`‘
`
`'
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`
`
`
`
`
`
`
`
`
`
`
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`
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`Application Number: 020717
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPROVAL LETTER
`
`
`
`
`
`NDA 20—71 7
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`Cephalon, Inc.
`Attention: Kenneth White, Pharm D
`
`145 Brandywine Parkway
`West Chester, PA 19380-4245
`
`Dear Dr. White:
`
`Please refer to your new drug application (NDA) dated December 27, 1996, received
`December 30, 1996, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act for PROVIGIL (modafinil) Tablets.
`
`We acknowledge receipt of your submissions dated March 30, May 6, June 4 and 30,
`July 27, October 9 and 30, November 11, and December 14 and 16, 1998.
`
`This new drug application provides for the use of PROVIGIL (modafinil) Tablets for
`narcolepsy.
`
`We have completed the review of this application, as amended, and have concluded
`that adequate information has been presented to demonstrate that the drug product is
`safe and effective for use as recommended in the enclosed labeling text. Accordingly,
`the application is approved effective on the date of this letter.
`
`The final printed labeling (FPL) must be identical to the enclosed labeling (text for the
`package insert, immediate container and carton labels). Marketing the product with
`FPL that is not identical to the approved labeling text may render the product
`misbranded and an unapproved new drug.
`
`Please submit 20 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 NDA 20-717." Approval of this submission by FDA is not
`required before the labeling is used.
`
`We remind you of your Phase 4 commitments specified in your submissions dated
`March 30, and December 16, 1998. These commitments, along with any completion
`dates agreed upon, are listed below:
`
`
`
`
`
` NDA 20-717
`
`Page 2
`
`(b >(4)(CC>---------------------------------------------------------------------------------------
`
`Protocols, data, and final reports should be submitted to your lND for this product and a
`copy of the cover letter sent to this NDA.
`If an lND is not required to meet your Phase
`4 commitments, please submit protocols, data and final reports to this NDA as
`correspondence.
`In addition, under 21 CFR 314.82(b)(2)(vii), we request that you
`include a status summary of each commitment in your annual report to this NDA. The
`status summary should include the number of patients entered in each study, expected
`completion and submission dates, and any changes in plans since the last annual
`report. For administrative purposes, all submissions, including labeling supplements,
`relating to these Phase 4 commitments must be clearly designated “Phase 4
`Commitments.”
`
`Validation of the regulatory methods has not been completed. At the present time, it is
`the policy of the Center not to withhold approval because the methods are being
`validated. Nevertheless, we expect your continued cooperation to resolve any
`problems that may be identified.
`
`In addition, please submit three copies of the introductory promotional materials that
`you propose to use for this product. All proposed materials should be submitted in draft
`or mock-up form, not final print. Please send one copy to the Division of
`Neuropharmacological Drug Products and two copies of both the promotional materials
`and the package insert directly to:
`
`
`
`
`
`
`
`NDA 20-717
`
`Page 3
`
`
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`
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`
`
`
`
`Division of Drug Marketing, Advertising, and Communications, HFD-40
`Food and Drug Administration
`5600 Fishers Lane
`
`Rockville, Maryland 20857
`
`Please submit one market package of the drug product when it is available.
`
`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 M. Homonnay-Weikel, R.Ph., Project Manager,
`at (301) 594-5535.
`
`Sincerely,
`
`/5/
`/S/
`
`Robert Temple, MD.
`Director
`
`Office of Drug Evaluation |
`Center for Drug Evaluation and Research
`
`Enclosure
`
`
`
`
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