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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 209091/S-002
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`Food and Drug Administration
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` Silver Spring, MD 20993
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`SUPPLEMENT APPROVAL
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` AstraZeneca AB
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` Attention: Ajay Parashar, B, Pharm., M.S., M.D.D., RAC
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` Regulatory Affairs Director
` One MedImmune Way
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` Gaithersburg, MD 20878
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`Dear Mr. Parashar:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received July 2,
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`2018, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Qtern (dapagliflozin and saxagliptin) tablets.
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`This Prior Approval supplemental new drug application provides for an expanded indication of
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`Qtern for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2
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`diabetes mellitus, and for a low dose (dapagliflozin 5 mg/saxagliptin 5 mg) of your product.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`text.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
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`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the Prescribing Information and
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`Medication Guide), with the addition of any labeling changes in pending “Changes Being
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`Reference ID: 4428080
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` NDA 209091/S-002
` Page 2
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` Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
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`labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
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`“SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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` Also within 14 days, amend all pending supplemental applications that include labeling changes
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` for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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` with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word format, that includes the
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` changes approved in this supplemental application, as well as annual reportable changes. To
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` facilitate review of your submission(s), provide a highlighted or marked-up copy that shows all
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` changes, as well as a clean Microsoft Word version. The marked-up copy should provide
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` appropriate annotations, including supplement number(s) and annual report date(s).
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` CARTON AND CONTAINER LABELING
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`We acknowledge your May 1, 2019, submission containing final printed carton and container
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`labeling.
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
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`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
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`assessment of the safety and effectiveness of the product for the claimed indication in pediatric
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`patients unless this requirement is waived, deferred, or inapplicable.
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`We are waiving the pediatric studies requirement for this application because necessary studies
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`are impossible or highly impracticable to complete because the number of available patients for
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`whom participation in such studies would be appropriate is expected to be very small.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
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`(3) the Prescribing Information to:
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`Reference ID: 4428080
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` NDA 209091/S-002
` Page 3
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` OPDP Regulatory Project Manager
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` Food and Drug Administration
` Center for Drug Evaluation and Research
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` Office of Prescription Drug Promotion (OPDP)
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` 5901-B Ammendale Road
` Beltsville, MD 20705-1266
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`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
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` Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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`You must submit final promotional materials and Prescribing Information, accompanied by a
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`Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)].
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`Form FDA 2253 is available at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Richard Whitehead, M.S., Regulatory Project Manager, at (301)
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`796-4945.
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`Sincerely,
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`{See appended electronic signature page}
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`Lisa B. Yanoff, M.D.
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`Director (Acting)
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`Division of Metabolism and Endocrinology Products
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`Office of Drug Evaluation II
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`Content of Labeling
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`Prescribing Information
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`Medication Guide
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`Carton and Container Labeling
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`Reference ID: 4428080
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`Signature Page 1 of 1
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`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.
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`/s/
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`LISA B YANOFF
`05/02/2019 04:46:29 PM
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`Reference ID: 4428080
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`(
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