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`ADMINISTRATION
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`NDA 210875/S-007
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`SUPPLEMENT APPROVAL
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` Sunovion Pharmaceuticals Inc
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`Attention: Rachel Morrison
` Associate Director, Global Regulatory Affairs
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`84 Waterford Drive
` Marlborough, MA 01752
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`Dear Ms. Morrison:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`February 23, 2022, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Kynmobi (apomorphine
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`hydrochloride) sublingual film.
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`We also refer to our letter dated January 28, 2022, notifying you, under Section
`505(o)(4) of the FDCA, of new safety information that we believe should be included in
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`the labeling for apomorphine products. This information pertains to the risk of hemolytic
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`anemia.
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`This supplemental new drug application provides for revisions to the labeling for
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`Kynmobi consistent with our January 28, 2022, letter.
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling text for the
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`Prescribing Information, Patient Package Insert, and Instructions for Use with the
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`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
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`labeling.
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 4979043
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`

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` NDA 210875/S-007
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` Page 2
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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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 include labeling
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
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`annual reportable changes. To facilitate review of your submission(s), provide a
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`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
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`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 labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.2
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.3 Information and
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`Instructions for completing the form can be found at FDA.gov.4
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`All promotional materials that include representations about your drug product must be
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`promptly revised to be consistent with the labeling changes approved in this
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`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
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`in your promotional materials should include prominent disclosure of the important new
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`safety information that appears in the revised labeling. Within 7 days of receipt of this
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`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
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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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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4979043
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`

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` NDA 210875/S-007
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` Page 3
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`If you have any questions, contact Jack Dan, Regulatory Project Manager, at
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`Jack.Dan@fda.hhs.gov.
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` Sincerely,
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`{See appended electronic signature page}
`
`
`Teresa Buracchio, MD
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`Director
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`Division of Neurology 1
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`Office of Neuroscience
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`• Content of Labeling
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`o Prescribing Information
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`o Patient Package Insert
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`Instructions for Use
`o
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`U.S. Food and Drug Administration
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`
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4979043
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`

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`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/
`------------------------------------------------------------
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`TERESA J BURACCHIO
`05/05/2022 08:59:51 AM
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`Reference ID: 4979043
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`