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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 020717/S-037 and 038
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`Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` Cephalon, Inc.
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` Attention: Adam Uchimoto
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` Associate, Regulatory Affairs
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` 41 Moores Road
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` Box 4011
` Frazer, PA 19355
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`Dear Mr. Uchimoto:
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`Please refer to your Supplemental New Drug Applications (sNDAs): Supplement 37 was dated
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`June 11, 2010, received June 14, 2010, and Supplement 38 was dated June 30, 2011, received
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`July 1, 2011, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
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`(FDCA) for Provigil (modafinil) Tablets.
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`We acknowledge receipt of your amendment for Supplement 37 dated February 17, 2011.
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`Supplement 37 is a “Prior Approval” supplemental new drug application that provides for
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`revisions to the Nursing Mothers, Adverse Drug Reactions, and Overdose sections of the
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`labeling.
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`Supplement 38 is a “Prior Approval” supplemental new drug application that provides for
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`compliance with the final rule, “Requirements on Content and Format of Labeling for Human
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`Prescription Drug and Biological Products” that was published January 24, 2006 (21 CFR parts
`201, 314, and 601).
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications, as amended, and they are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
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`upon labeling text.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the package insert and Medication
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`Guide), with the addition of any labeling changes in pending “Changes Being Effected” (CBE)
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`supplements, as well as annual reportable changes not included in the enclosed labeling.
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`Reference ID: 3685660
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` NDA 020717/S-037 and 038
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` Page 2
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` Information on submitting SPL files using eList may be found in the guidance for industry titled
` “SPL Standard for Content of Labeling Technical Qs and As at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
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`The SPL will be accessible from publicly available labeling repositories.
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` Also within 14 days, amend all pending supplemental applications that includes labeling changes
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` for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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` with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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` changes approved in this supplemental application, as well as annual reportable changes and
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` annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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` up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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` should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
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` PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion (OPDP)
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
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`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`Reference ID: 3685660
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` If you have any questions, call Susan Daugherty, Regulatory Project Manager, at
` (301) 796-0878.
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`Sincerely,
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`{See appended electronic signature page}
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`Eric Bastings, MD
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`Deputy Director
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`Division of Neurology Products
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`Office of Drug Evaluation I
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`Center for Drug Evaluation and Research
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` NDA 020717/S-037 and 038
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` Page 3
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`ENCLOSURE(S):
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`Content of Labeling
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`Reference ID: 3685660
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`ERIC P BASTINGS
`01/15/2015
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`Reference ID: 3685660
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`