DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Silver Spring MD 20993

NDA 208065/S-02
SUPPLEMENT APPROVAL
AstraZeneca Pharmaceuticals LP
Attention: Jonathan Jazayeri, Pharm.D., M.S., R.A.C.
Regulatory Affairs Director, Oncology
One MedImmune Way
Gaithersburg, MD 20878
Dear Dr. Jazayeri:
Please refer to your Supplemental New Drug Application (sNDA) dated February 12, 2016,
received February 12, 2016, submitted under section 505(b) of the Federal Food, Drug, and
Cosmetic Act (FDCA) for TAGRISSO (osimertinib), 40 mg and 80 mg tablets.
This Prior Approval supplemental new drug application provides for the following updates to the
package insert:
  Based on data from four drug-drug interaction studies the Dosage and Administration,
Dosage Modification subsection; Drug Interactions, Effect of Other Drugs on
Osimertinib and Effect of Osimertinib on Other Drugs subsections; Use in Specific
Populations Females and Males of Reproductive Potential subsection, Renal Impairment,
and Hepatic Impairment subsections; and the Clinical Pharmacology; Pharmacokinetics
subsection was updated to include information regarding strong CYP3A inducers and
strong CYP3A inhibitors.
  Based on data from one non-clinical fertility and early embryonic development study the
Nonclinical Toxicology, Carcinogenesis, Mutagenesis, Impairment of Fertility subsection
was updated to include information regarding potential female fertility impairment.
  The Dosage and Administration, Administration to Patients Who Have Difficulty 

Swallowing Solids subsection was updated to include dissolution information when 

osimertinib administration via a naso-gastric tube is required. 

In addition, the Patient Information was updated to reflect updates made in the package insert.
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.

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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 include 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.

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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 at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM443702.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.
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 Ingrid Fan, Regulatory Project Manager, at (301) 796-5053.
Sincerely,
{See appended electronic signature page}
Jeffery Summers, M.D.
Deputy Director for Safety
Division of Oncology Products 2
Office of Hematology and Oncology Products
Center for Drug Evaluation and Research
ENCLOSURE(S): Content of Labeling

Reference ID: 3971806

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------JEFFERY L SUMMERS
08/12/2016

Reference ID: 3971806