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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 020717 / S-040 and 041
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` NDA 021875 / S-016 and 017
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
`REMS ASSESSMENT ACKNOWLEDGEMENT
`RELEASE REMS REQUIREMENT
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`
`Cephalon, Inc.
`Attention: Paul Kirsch
`Senior Director and Group Leader
`Regulatory Affairs
`PO Box 4011
`41 Moores Road
`Frazer, PA 19355
`
`Dear Mr. Kirsch:
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated October 20, 2011 and
`January 9, 2012, respectively, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Provigil (modafinil) tablets and Nuvigil (armodafinil) tablets.
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`sNDAs 020717/S-0040and 021875/S-016 contain an assessment of the risk evaluation and
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`mitigation strategy (REMS) for Provigil (modafinil) and Nuvigil (armodafinil). After
`consultation between the Office of Surveillance and Epidemiology and the Office of New Drugs,
`we found the REMS assessment to be complete.
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`sNDAs 020717/S-0041 and 021875/S-017 are Prior Approval supplemental new drug
`applications that propose to eliminate the requirement for the approved Provigil (modafinil) and
`Nuvigil (armodafinil) REMS. We have completed our review of these supplemental applications
`and they are approved, effective on the date of this letter.
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`
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`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
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`The REMS for Provigil (modafinil) and Nuvigil (armodafinil) were originally approved on
`October 21, 2010. The REMS consist of a Medication Guide, a communication plan, and a
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`timetable for submission of assessments of the REMS.
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`You propose that FDA no longer require a REMS for Provigil (modafinil) and Nuvigil
`(armodafinil).
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`We have determined that maintaining the Medication Guide as part of the approved labeling is
`adequate to address the serious and significant public health concern and meets the standard in
`21 CFR 208.1. Therefore, it is no longer necessary to include the Medication Guide as an
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`Reference ID: 3072149
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`

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` NDA 020717/S-040 and 041
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` NDA 021875/S-016 and 017
`Page 2
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`element of the approved REMS to ensure that the benefits of Provigil (modafinil) and Nuvigil
`(armodafinil) outweigh their risks.
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`The REMS assessment submitted on October 20, 2011 demonstrated that the key components of
`the communication plan (the distribution of Dear Healthcare Professional letters, Prescriber
`Brochures, and Pharmacist Action letters following REMS approval) have been completed.
`Although the assessment suggested that understanding of the risk of serious skin reactions by
`physicians is not optimal, we have determined that the risk of serious skin reactions is likely to
`be lower than expected at the time of the drugs’ approval, and it is no longer necessary to include
`the communication plan as an element of the approved REMS to ensure that the benefits of the
`Provigil and Nuvigil outweigh the risks.
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`Therefore, we agree with your proposal to eliminate the REMS for Provigil (modafinil) and
`Nuvigil (armodafinil).
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`We remind you that the Medication Guide will continue to be part of the approved labeling in
`accordance with 21 CFR 208.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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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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`
`Russell G. Katz, M.D.
`Director
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`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`Reference ID: 3072149
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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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`RUSSELL G KATZ
`01/13/2012
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`Reference ID: 3072149
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