`
`NDA 021897/S-042
`
`Alkermes, Inc.
`852 Winter Street
`Waltham, MA 02451-1420
`
`Attention:
`
`Ankith Devunapalli, M.S., MBA
`Senior Associate, Regulatory Affairs
`
`Dear Mr. Devunapalli:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received June 29,
`2018, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug,
`and Cosmetic Act (FDCA) for VIVITROL (naltrexone for extended-release injectable
`suspension).
`
`This Prior Approval supplemental new drug application proposes revisions to the USE IN
`SPECIAL POPULATIONS section of the Package Insert to conform with the Pregnancy and
`Lactation Labeling Rule (PLLR), and to meet the requirements of 21 CFR 201.56 (a and d) and
`201.57(c)(9)(i, ii, and iii).
`
`APPROVAL & LABELING
`
`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the Prescribing Information), with
`
`Reference ID: 4368785
`
`
`
`NDA 021897/S-042
`Page 2
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`the addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements,
`as well as annual reportable changes not included in the enclosed labeling.
`
`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
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications that include labeling changes
`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
`with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes. To
`facilitate review of your submission(s), provide a highlighted or marked-up copy that shows all
`changes, as well as a clean Microsoft Word version. The marked-up copy should provide
`appropriate annotations, including supplement number(s) and annual report date(s).
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Swati Patwardhan, Regulatory Project Manager, at 301-796-4085.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Rigoberto Roca, MD
`Deputy Director
`Division of Anesthesia, Analgesia,
`and Addiction Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`ENCLOSURE(S):
`Content of Labeling
`Prescribing Information
`
`Reference ID: 4368785
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`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.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`RIGOBERTO A ROCA
`12/28/2018 09:25:09 AM
`
`Reference ID: 4368785
`
`