DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Silver Spring MD 20993

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
SUPPLEMENT APPROVAL
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

 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

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, agreedupon 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 markedup 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 

NDA 021444 S-051 

NDA 020588 S-065 

NDA 021999 S-030 

NDA 207946 S-001 

Page 3 


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

 --------------------------------------------------------------------------------------------------------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
(