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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 021346 S-055
`NDA 022264 S-019
`NDA 020272 S-077
`NDA 021444 S-051
`NDA 020588 S-065
`NDA 021999 S-030
`NDA 207946 S-001
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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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`
`Janssen Pharmaceuticals, Inc.
`
`
`Attention: Jacqueline Brown, R.Ph.
`
`Associate Director, Global Regulatory Affairs
`
`1125 Trenton-Harbourton Road
`
`P.O. Box 200
`Titusville, NJ 08560-0200
`
`Dear Ms. Brown:
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated and received April 28,
`2015 (Risperdal Consta) and April 30, 2015 (Invega Sustenna), submitted under section 505(b)
`of the Federal Food, Drug, and Cosmetic Act for Risperdal Consta (risperidone) long acting
`injection, 12.5 mg, 25 mg, 37.5 mg, and 50 mg (NDA 021346) and for Invega Sustenna
`(paliperidone palmitate) extended-release injectable suspension, 39 mg, 78 mg, 117 mg, 156 mg,
`and 234 mg (NDA 022264).
`
`We acknowledge receipt of your amendments dated February 12, 2016, which constituted a
`complete response to our October 1, 2015, action letter.
`
`Please also refer to your Supplemental New Drug Applications (sNDAs) dated and received
`February 16, 2016, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`for Risperdal (risperidone) Tablets 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4 mg (NDA 020272),
`Risperdal (risperidone) Oral Solution 1 mg/mL (NDA 020588), Risperdal M-Tabs (risperidone)
`Orally Disintegrating Tablets 0.5mg, 1mg, 2mg, 3mg, 4mg (NDA 021444 ), Invega
`(paliperidone) Extended Release (ER) Tablets 1.5mg, 3mg, 6mg, 9mg, 12 mg (NDA 021999),
`and Invega Trinza (paliperidone palmitate) extended-release injectable suspension 273mg,
`410mg, 546mg, 819mg (NDA 207946)
`
`These “Prior Approval” supplemental new drug applications provide for additions regarding
`hypersensitivity reactions to HIGHLIGHTS OF PRESCRIBING INFORMATION and
`CONTRAINDICATIONS sections of labeling.
`
`
`
`
`Reference ID: 3894692
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`
`
`NDA 021346 S-055
`NDA 022264 S-019
`NDA 020272 S-077
`NDA 021444 S-051
`NDA 020588 S-065
`NDA 021999 S-030
`NDA 207946 S-001
`Page 2
`
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`APPROVAL & LABELING
`
`We have completed our review of these supplemental applications, as amended. They are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text.
`
`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 package insert, text for the
`
` patient package insert), with 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 includes 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 MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, 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).
`
`
`
`Reference ID: 3894692
`
`
`
`NDA 021346 S-055
`
`NDA 022264 S-019
`
`NDA 020272 S-077
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`NDA 021444 S-051
`
`NDA 020588 S-065
`
`NDA 021999 S-030
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`NDA 207946 S-001
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`Page 3
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`
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`If you have any questions, call Keith Kiedrow, Pharm.D, MS, RAC, Senior Regulatory Project
`Manager, at (301) 796-1924.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`
`Mitchell V. Mathis, M.D.
`
`
` Director
`
`Division of Psychiatry Products
`
`Office of Drug Evaluation I
`
`Center for Drug Evaluation and Research
`
`
`Reference ID: 3894692
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`
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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/
`----------------------------------------------------
`
`MITCHELL V Mathis
`03/01/2016
`
`Reference ID: 3894692
`
`(
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