NDA 021897/S-055
`
`Alkermes, Inc.
`852 Winter Street
`Waltham, MA 02451
`
`SUPPLEMENT APPROVAL
`
`Attention:
`
`Divyani Patel, PharmD
`Senior Associate, Regulatory Affairs
`
`
`Dear Dr. Patel:
`
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`
`
`April 2, 2021, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`Act (FDCA) for Vivitrol (naltrexone for extended-release injectable suspension).
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`
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`This prior approval supplemental new drug application provides for proposed
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`
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`modifications to the approved Vivitrol risk evaluation and mitigation strategy (REMS).
`
`This supplement is in response to our March 17, 2021, REMS Modification Notification
`letter / REMS Assessment Acknowledgment letter.
`
`APPROVAL
`
`
`
`
`We have completed our review of this supplemental application. It is approved effective
`on the date of this letter.
`
`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
`
`The REMS for Vivitrol (naltrexone) was originally approved on March 22, 2010, and the
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`most recent REMS modification was approved on June 7, 2019. The REMS consists of
`a Medication Guide, a communication plan, and a timetable for submission of
`assessments of the REMS.
`
`
`In accordance with section 505-1 of the FDCA, we have determined that the following
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`REMS modifications are necessary to minimize burden on the healthcare delivery
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`system of complying with the REMS:
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` Removal of the Medication Guide as an element of the REMS
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` Removal of the communication plan
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`
`Reference ID: 4791701
`
`

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`NDA 021897/S-055
`Page 2
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` We have determined that maintaining the Medication Guide as part of the approved
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`labeling is adequate to address the serious and significant public health concern and
`meets the standard in 21 CFR 208. Therefore, it is no longer necessary to include the
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`Medication Guide as an element of the approved REMS to ensure that the benefits of
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`Vivitrol (naltrexone) outweigh its risks. The Medication Guide will remain as part of the
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`approved labeling in accordance with 21 CFR 208. Like other labeling, Medication
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`Guides are subject to the safety labeling change provisions of section 505(o)(4) of the
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`
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`FDCA.
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`Additionally, we have determined that the communication plan is no longer necessary to
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`ensure the benefits of VIVITROL (naltrexone) outweigh its risks because the
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`communication plan has been completed. The most recent REMS assessment
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`demonstrates that the communication plan has met its goals and has shown that
`healthcare provider respondents were aware of the risk of severe injection site reactions
`and the need to counsel patients regarding risks. Patient survey respondents were less
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`able to identify all of the symptoms of severe injection site reactions, but were well
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`aware that they should contact their healthcare provider about any reaction at the
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`injection site that was concerning or got worse over time.
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`Therefore, because the Medication Guide (as part of the REMS) and communication
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`plan are no longer necessary to ensure the benefits of the drug outweigh the risks, a
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`REMS is no longer required for Vivitrol (naltrexone).
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`As previously stated, the Medication Guide will remain as part of the approved labeling
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`for Vivitrol (naltrexone).
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`REPORTING REQUIREMENTS
`
`
`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 LCDR Jessica Voqui, PharmD, MS, Safety Regulatory
`Project Manager, at 301-796-2915.
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`LCDR Mark A. Liberatore, PharmD, RAC
`Deputy Director for Safety
`Division of Anesthesiology, Addiction Medicine,
`and Pain Medicine
`Office of Neuroscience
`
`Center for Drug Evaluation and Research
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4791701
`
`

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`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
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`/s/
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`MARK A LIBERATORE
`05/06/2021 04:45:29 PM
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`Reference ID: 4791701
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