DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Silver Spring MD 20993

NDA 207931/S-001
SUPPLEMENT APPROVAL
AbbVie Inc.
Attention: Glen W. Spears, Ph.D.
Director, Regulatory Affairs
1 N. Waukegan Road, Dept. PA77/Bldg. AP30
North Chicago, IL 60064
Dear Dr. Spears:
Please refer to your Supplemental New Drug Application (sNDA) dated October 21, 2015,
received October 21, 2015, submitted under section 505(b) of the Federal Food, Drug, and
Cosmetic Act (FDCA) for TECHNIVIE (ombitasvir, paritaprevir, and ritonavir) tablets.
This “Changes Being Effected” supplemental new drug application provides for the following
revisions:
•  To update the INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION,
CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, ADVERSE
REACTIONS, USE IN SPECIFIC POPULATIONS, CLINICAL PHARMACOLOGY,
and PATIENT COUNSELING INFORMATION sections of the Package Insert and
Medication Guide with information on postmarketing cases of hepatic decompensation
and hepatic failure with TECHNIVIE. In addition, CONTRAINDICATIONS section was
updated with information regarding contraindication of Colchicine use with
TECHNIVIE.
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.
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,
Medication Guide), with the addition of any labeling changes in pending “Changes Being

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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/
UCM072392.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).
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 the following, in triplicate, (1) a cover letter requesting advisory
comments, (2) the proposed materials in draft or mock-up form with annotated references, and
(3) the package insert(s) to:
OPDP Regulatory Project Manager
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Prescription Drug Promotion (OPDP)
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

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at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance
s/UCM443702.pdf ).
You must submit final promotional materials and package insert(s), accompanied by a Form
FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. 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.
All promotional materials that include representations about your drug product must be promptly
revised to be consistent with the labeling changes approved in this supplement, including any
new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
should include prominent disclosure of the important new safety information that appears in the
revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
to comply with 21 CFR 314.70(a)(4) to the address above, by fax to 301-847-8444, or
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/Guidance
s/UCM443702.pdf ).
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 Kyong Hyon, Safety Regulatory Project Manager, at (301) 796­
0734.
Sincerely,
{See appended electronic signature page}
Poonam Mishra, MD, MPH
Deputy Director for Safety
Division of Antiviral Products
Office of Antimicrobial Products
Center for Drug Evaluation and Research
ENCLOSURE:
Content of Labeling

Reference ID: 3837135

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------KYONG M HYON
10/22/2015
POONAM MISHRA
10/22/2015

Reference ID: 3837135