`
`
`
`Food and Drug Administration
`
`
` Silver Spring, MD 20993
`
`
`
`
` NDA APPROVAL
`
`
`
`AstraZeneca AB
`
`Attention: Ajay Parashar, B.Pharm., M.S., M.D.D., R.A.C.
`
`
`Director, Global Regulatory Affairs
`
`One MedImmune Way
`
`Gaithersburg, MD 20878
`
`
`
`Dear Mr. Parashar:
`
`
`
`
`
`
`
`
`
`
`Please refer to your New Drug Application (NDA) dated and received July 2, 2018, and your
`
`
`amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`
`(FDCA) for Qternmet XR (dapagliflozin, saxagliptin, and metformin hydrochloride) extended-
`
`release tablets.
`
`
`
`This new drug application provides for the use of Qternmet XR (dapagliflozin, saxagliptin, and
`
`
`
`metformin hydrochloride) extended-release tablets as an adjunct to diet and exercise to improve
`
`glycemic control in adults with type 2 diabetes mellitus.
`
`
`APPROVAL & LABELING
`
`
`
`
`
`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 ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`
`
`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) 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 SPL
`
`
`
`
`
`
`Standard for Content of Labeling Technical Qs and As, available at
`
`
`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
` NDA 210874
`
`
`
`
`
`Reference ID: 4428078
`
`

`

`
`
`
`
`
`
` NDA 210874
`
`
` Page 2
`
`
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`
` CM072392.pdf
`
` The SPL will be accessible via publicly available labeling repositories.
`
`
`CARTON AND CONTAINER LABELING
`
`
`
`We acknowledge your May 1, 2019, submission containing final printed carton and container
`
`labeling.
`
`
`ADVISORY COMMITTEE
`
`
`
`Your application for Qternmet XR was not referred to an FDA advisory committee because these
`
`
`
`
`drugs are not the first in its class.
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
` Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`
`
` active ingredients (which includes new salts and new fixed combinations), 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 in pediatric
` patients unless this requirement is waived, deferred, or inapplicable.
`
`
` We are waiving the pediatric studies requirement for this application because necessary studies
`
`
`
`
`
`
`
`are impossible or highly impracticable to complete because the 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 Prescribing
`
`
`Information, Medication Guide, and Patient Package Insert (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/
`
`
`UCM443702.pdf ).
`
`Reference ID: 4428078
`
`

`

`
`
` NDA 210874
`
`
` Page 3
`
`
` As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`
`
` Prescribing Information, 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 Richard Whitehead, M.S., Regulatory Project Manager, at (301)
`
`
`796-4945.
`
`
`
`
`
`
`
`
`Sincerely,
`
`
` {See appended electronic signature page}
`
` Lisa B. Yanoff, M.D.
`
`
` Director (Acting)
` Division of Metabolism and Endocrinology Products
`
`
` Office of Drug Evaluation II
` Center for Drug Evaluation and Research
`
`
`
`
`
`
` ENCLOSURES:
`
`
`
` Content of Labeling
` Prescribing Information
`
` Medication Guide
`
` Carton and Container Labeling
`
`
`
`
`
`Reference ID: 4428078
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`LISA B YANOFF
`05/02/2019 04:44:50 PM
`
`Reference ID: 4428078
`
`(
`
`
`
`