DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993

NDA 208216
NDA APPROVAL
Actavis, LLC
Attention: Joann Stavole, MS, RAC
Director, Regulatory Affairs
400 Interpace Parkway
Morris Corporate Center III, Building D, 3rd Floor
Parsippany, NJ 07054

Dear Ms. Stavole:
Please refer to your New Drug Application (NDA) dated June 30, 2015, received June 30, 2015,
and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act (FDCA) for Azacitidine for Injection, 100 mg/vial for subcutaneous or intravenous
use.
This new drug application provides for the use of Azacitidine for Injection for the treatment of
patients with the following French-American-British (FAB) myelodysplastic syndrome (MDS)
subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if
accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia
with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T),
and chronic myelomonocytic leukemia (CMMoL).
We have completed our review of this application, as amended. It is 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 and Medication
Guide). Information on submitting SPL files using eLIST may be found in the guidance for
industry SPL Standard for Content of Labeling Technical Qs and As, available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM072392.pdf.

Reference ID: 3924281

 NDA 208216
Page 2

The SPL will be accessible via publicly available labeling repositories.
CARTON AND IMMEDIATE CONTAINER LABELS
We acknowledge your April 14, 2016, submission containing final printed carton and container
labels.
PROPRIETARY NAME
If you intend to have a proprietary name for this product, the name and its use in the labels must
conform to the specifications under 21 CFR 201.10 and 201.15. We recommend that you submit
a request for a proposed proprietary name review. (See the guidance for industry Contents of a
Complete Submission for the Evaluation of Proprietary Names, available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/u
cm075068.pdf and “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years
2008 through 2012”).
REQUIRED PEDIATRIC ASSESSMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
administration are required to contain an assessment of the safety and effectiveness of the
product for the claimed indication(s) in pediatric patients unless this requirement is waived,
deferred, or inapplicable.
Because none of these criteria apply to your application, you are exempt from this requirement.
PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional
labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
proposed materials in draft or mock-up form with annotated references, and the package insert,
Medication Guide, and patient PI (as applicable) to:
OPDP Regulatory Project Manager

Food and Drug Administration 

Center for Drug Evaluation and Research

Office of Prescription Drug Promotion

5901-B Ammendale Road

Beltsville, MD 20705-1266

Alternatively, you may submit a request for advisory comments electronically in eCTD format.
For more information about submitting promotional materials in eCTD format, see the draft
Guidance for Industry (available at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM443702.pdf).

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As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
package insert, at the time of initial dissemination or publication, accompanied by a Form
FDA 2253. Form FDA 2253 is available at:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
Information and Instructions for completing the form can be found at:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
more information about submission of promotional materials to the Office of Prescription Drug
Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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, contact Tracy Cutler, Regulatory Health Project Manager, at
(301) 796-9608 or Tracy.Cutler@fda.hhs.gov.
Sincerely,
{See appended electronic signature page}

Ann T. Farrell, MD
Director
Division of Hematology Products
Office of Hematology and Oncology Products
Center for Drug Evaluation and Research

Enclosure(s):
Content of Labeling
Carton and Container Labeling

Reference ID: 3924281

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------ANN T FARRELL
04/29/2016

Reference ID: 3924281