DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Silver Spring MD 20993

NDA 205718/S-003
SUPPLEMENT APPROVAL
FULFILLMENT OF POSTMARKETING COMMITMENT
Helsinn Healthcare SA
Attention: Craig Lehmann
August Consulting, Inc.
515 Capital of Texas Highway, Suite 150
Austin, TX 78746

Dear Mr. Lehmann:
Please refer to your Supplemental New Drug Application (sNDA) dated and received
October 30, 2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
(FDCA) for Akynzeo (netupitant-palonosetron hydrochloride) capsules.
This “Prior Approval” supplemental new drug application proposes to update the
Pharmacokinetics, Drug Interactions section of the package insert to reflect data from in vitro
study reports NETU-14-30 and NETU-13-47; both submitted in support of fulfilling
postmarketing commitment 2769-5.
APPROVAL & LABELING
We have completed our review of this supplemental application. 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 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

Reference ID: 3740363

 NDA 205718/S-003
Page 2

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).
FULFILLMENT OF POSTMARKETING COMMITMENT
We have received your submission dated October 30, 2014, reporting on the following
postmarketing commitment listed in the October 10, 2014, approval letter.
2769-5 In vitro study to evaluate the potential of netupitant to act as a substrate for P-gp
transporter in a bi-directional transport assay system.
We have reviewed your submission and conclude that the above commitment was fulfilled.
We remind you that there are postmarketing commitment listed in the October 10, 2014,
approval letter that are still open.
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 Heather Buck, Regulatory Project Manager, at (301) 796-1413.
Sincerely,
{See appended electronic signature page}
Joyce Korvick, M.D., M.P.H.
Deputy Director for Safety
Division of Gastroenterology and Inborn Errors Products
Office of Drug Evaluation III
Center for Drug Evaluation and Research
ENCLOSURE: Content of Labeling

Reference ID: 3740363

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------JOYCE A KORVICK
04/27/2015

Reference ID: 3740363