NDA 20-717 Cephalon, Inc.Attention: Kenneth White, Pharm D145 Brandywine ParkwayWest Chester, PA 19380-4245Dear Dr. White: Please refer to your new drug application (NDA) dated December 27, 1996, receivedDecember 30, 1996, submitted under section 505(b) of the Federal Food, Drug, andCosmetic 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 fornarcolepsy.We have completed the review of this application, as amended, and have concludedthat adequate information has been presented to demonstrate that the drug product issafe 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 thepackage insert, immediate container and carton labels). Marketing the product withFPL that is not identical to the approved labeling text may render the productmisbranded and an unapproved new drug.Please submit 20 copies of the FPL as soon as it is available, in no case more than 30days after it is printed. Please individually mount ten of the copies on heavy-weightpaper or similar material. For administrative purposes, this submission should bedesignated "FPL for approved NDA 20-717." Approval of this submission by FDA is notrequired before the labeling is used.We remind you of your Phase 4 commitments specified in your submissions datedMarch 30, and December 16, 1998. These commitments, along with any completiondates agreed upon, are listed below:
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`NDA 20-717Page 2(b)(4)(CC)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Protocols, data, and final reports should be submitted to your IND for this product and acopy of the cover letter sent to this NDA. If an IND is not required to meet your Phase4 commitments, please submit protocols, data and final reports to this NDA ascorrespondence. In addition, under 21 CFR 314.82(b)(2)(vii), we request that youinclude a status summary of each commitment in your annual report to this NDA. Thestatus summary should include the number of patients entered in each study, expectedcompletion and submission dates, and any changes in plans since the last annualreport. For administrative purposes, all submissions, including labeling supplements,relating to these Phase 4 commitments must be clearly designated “Phase 4Commitments.”Validation of the regulatory methods has not been completed. At the present time, it isthe policy of the Center not to withhold approval because the methods are beingvalidated. Nevertheless, we expect your continued cooperation to resolve anyproblems that may be identified.In addition, please submit three copies of the introductory promotional materials thatyou propose to use for this product. All proposed materials should be submitted in draftor mock-up form, not final print. Please send one copy to the Division ofNeuropharmacological Drug Products and two copies of both the promotional materialsand the package insert directly to:
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`NDA 20-717Page 3Division of Drug Marketing, Advertising, and Communications, HFD-40Food and Drug Administration5600 Fishers LaneRockville, Maryland 20857Please 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 setforth 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,Robert Temple, M.D.DirectorOffice of Drug Evaluation ICenter for Drug Evaluation and ResearchEnclosure
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