`
`Approval Package for:
`
`APPLICATION NUMBER:
`
`209091Orig1s000
`
`
` Qtern tablets 10mg/5mg
`
`dapagliflozin and saxagliptin
`
`
`
`Trade Name:
`
`Generic or Proper
`Name:
`
`Sponsor:
`
`
`
`
`Approval Date:
`
`
`Indication:
`
`
`AstraZeneca Pharmaceuticals LP
`
`February 27, 2017
`
`As an adjunct to diet and exercise to improve glycemic
`control in adults with type 2 diabetes mellitus (T2DM)
`who have inadequate control with dapagliflozin or who
`are already treated with dapagliflozin and saxagliptin
`
`
`
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`209091Orig1s000
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Clinical Review(s)
`Product Quality Review(s)
`Non-Clinical Review(s)
`Statistical Review(s)
`Clinical Microbiology / Virology Review(s)
`Clinical Pharmacology/Biopharmaceutics Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`
`X
`
`X
`
`X
`X
`
`X
`X
`X
`X
`X
`
`X
`X
`
`X
`X
`
`
`
`
`
`
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`209091Orig1s000
`
`
`APPROVAL LETTER
`
`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`NDA 209091
`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`NDA APPROVAL
`
`
`AstraZeneca Pharmaceuticlas LP
`US Agent for AstraZeneca AB
`Attention: Sally Walsh
`Director, Regulatory Affairs
`One MedImmune Way
`Gaithersburg, MD 20878
`
`
`Dear Ms. Walsh:
`
`Please refer to your New Drug Application (NDA) dated April 27, 2016, received
`April 27, 2016, and your amendments, submitted under section 505(b) of the Federal Food,
`Drug, and Cosmetic Act (FDCA) for Qtern (dapagliflozin and saxagliptin) tablets 10mg/5mg.
`
`This new drug application provides for the use of Qtern (dapagliflozin and saxagliptin) tablets as
`an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
`mellitus (T2DM) who have inadequate control with dapagliflozin or who are already treated with
`dapagliflozin and saxagliptin.
`
`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
`
`WAIVER OF HIGHLIGHTS SECTION
`
`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
`prescribing information. This waiver applies to all future supplements containing revised
`labeling unless we notify you otherwise.
`
`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 prescribing
`information 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
`
`Reference ID: 4062027
`
`
`
`NDA 209091
`Page 2
`
`
`at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances
`/UCM072392.pdf
`
`The SPL will be accessible via publicly available labeling repositories.
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`
`Submit final printed carton and immediate container labels that are identical to the: enclosed
`carton and immediate container labels submitted on February 24, 2017, as soon as they are
`available, but no more than 30 days after they are printed. Please submit these labels
`electronically according to the guidance for industry Providing Regulatory Submissions in
`Electronic Format — Certain Human Pharmaceutical Product Applications and Related
`Submissions Using the eCTD Specifications (May 2015, Revision 3). Alternatively, you may
`submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or
`similar material. For administrative purposes, designate this submission “Final Printed Carton
`and Container Labels for approved NDA 209091.” Approval of this submission by FDA is
`not required before the labeling is used.
`
`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.
`
`We are waiving the pediatric study requirement for this application because necessary studies are
`impossible or highly impracticable to complete because he number of available patients for
`whom participation in such studies would be appropriate is expected to be very small.
`
`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
`
`
`
`Reference ID: 4062027
`
`
`
`NDA 209091
`Page 3
`
`
`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/Guidance
`s/UCM443702.pdf ).
`
`
`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, call Abolade (Bola) Adeolu, Regulatory Project Manager, at
`(301) 796-4264.
`
`
`
`Enclosures:
` Prescribing Information
` Medication Guide
` Carton and Container Labeling
`
`Reference ID: 4062027
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Jean-Marc Guettier, MD
`Director
`Division of Metabolism & Endocrinology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JEAN-MARC P GUETTIER
`02/27/2017
`
`Reference ID: 4062027
`
`(
`
`
`
`