`
`( ~ rffl.l U.S. FOOD & DRUG
`
`• ,~ ~
`
`-
`
`ADMINISTRAT I ON
`
`
`
` NDA 204629/S-028; NDA 204629/S-029; NDA 206073/S-027; NDA 206073/S-030
`
` NDA 206111/S-025; NDA 206111/S-026; NDA 208658/S-013; NDA 208658/S-015
`
` NDA 212614/S-008; NDA 212614/S-010
`
`SUPPLEMENT APPROVAL
`
`
`
`
` Boehringer Ingelheim Pharmaceuticals, Inc.
`
` Attention: Agnieszka Abeyta, Pharm.D.
`
` Associate Director, Regulatory Affairs
`
` 900 Ridgebury Road
`
` P.O. Box 368
` Ridgefield, CT 06877
`
` Dear Dr. Abeyta:
`
` Please refer to your supplemental new drug applications (sNDAs) submitted under
`
`
`
` section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for the following:
`
`
`
`
`
`
`
`
`NDA
`Supplement
`
`
` Number
` Numbers
`
` 204629 28 and 29
`
`
`
`
` 206073 27 and 30
`
`
`
`
`
` 206111 25 and 26
`
`
`
`
`
` 208658 13 and 15
`
`
`
`
`
` 212614 8 and 10
`
`
`
`
`
` Product Name
`
`
`
` Receipt Dates
`
`Jardiance (empagliflozin)
`
` tablets
`
` Glyxambi (empagliflozin and
`
`
` linagliptin) tablets
`
` Synjardy (empagliflozin and
`
`
` metformin HCl) tablets
`
` Synjardy XR (empagliflozin
`
`
`and metformin HCl extended-
`
` release) tablets
` Trijardy XR (empagliflozin,
`
`linagliptin, and metformin
`hydrochloride extended-
`
`
` release) tablets
`
`November 3, 2021,
`
`and
` February 16, 2021
`
`November 16, 2021,
`
`and
` March 05, 2021
`
`
`
`November 16, 2021,
`
`and
` March 05, 2021
`
`November 16, 2021,
`
` and
` March 05, 2021
`
`
`
`November 16, 2021,
`
`and
` March 05, 2021
`
`
`
`
`
` These Prior Approval sNDAs provide for changes to the prescribing information (PI) and
`
`
`medication guide (MG) regarding volume depletion, acute kidney injury, and impairment
`
` in renal function. These supplements also provide for additional changes to the PI and
`MG to comply with current labeling guidance.
`
`
`
`Reference ID: 4810096
`
`
`
`
`
`
`
`
`
`
`
`
` NDA 204629/S-028; NDA 204629/S-029; NDA 206073/S-027; NDA 206073/S-030
`
` NDA 206111/S-025; NDA 206111/S-026; NDA 208658/S-013; NDA 208658/S-015
`
` NDA 212614/S-008; NDA 212614/S-010
`
` Page 2
`
`
` 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.
`
` WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
` Please note that we have previously granted a waiver of the requirements of 21 CFR
`
` 201.57(d)(8) regarding the length of Highlights of Prescribing Information.
`
` 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
`
` FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
` Prescribing Information and Medication Guide), 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 SPL Standard for Content of Labeling Technical Qs and As.2
`
` 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 Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
`highlighted or marked-up 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).
`
`
`
`
`
`
`
`
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`
`
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
` U.S. Food and Drug Administration
`
` Silver Spring, MD 20993
`
` www.fda.gov
`
`
`
`
`
`Reference ID: 4810096
`
`
`
`
`
`
`
`
`
`
` NDA 204629/S-028; NDA 204629/S-029; NDA 206073/S-027; NDA 206073/S-030
`
` NDA 206111/S-025; NDA 206111/S-026; NDA 208658/S-013; NDA 208658/S-015
`
` NDA 212614/S-008; NDA 212614/S-010
`
` Page 3
`
`
` PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`
`
` final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`Prescription Drugs. 3
`
`
`You must submit final promotional materials and Prescribing Information, 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 FDA.gov.4 Information and
`
`
` Instructions for completing the form can be found at FDA.gov.5
`
`
`
` 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 Shiva Salartash, Regulatory Project Manager, at
`
` 301-837-7568.
`
`
`
`
`
`
`
`
`
`
`
` Sincerely,
`
` {See appended electronic signature page}
`
` Lisa Yanoff, M.D.
`
` Deputy Director (Acting)
`
`Office of Cardiology, Hematology, Endocrinology,
`
` and Nephrology
` Office of New Drugs
`
` Center for Drug Evaluation and Research
`
`
`
`
`
`
`
` ENCLOSURES:
`
`• Content of Labeling for Jardiance, Glyxambi, Synjardy, Synjardy, XR, and
`
`
`
` Trijardy
`o Prescribing Information
`
`
`o Medication Guide
`
`
`
`
`
`
`
` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
`
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
`
`
` U.S. Food and Drug Administration
`
` Silver Spring, MD 20993
`
` www.fda.gov
`
`Reference ID: 4810096
`
`
`
`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
`06/11/2021 08:12:06 AM
`
`Reference ID: 4810096
`
`