(~Ji Ii U.S. FOOD & DRUG
`
`AD M IN I STRATIO N
`
`• ,~~\.-
`
`NDA 204629/S-034
`NDA 206073/S-031
`NDA 206111/S-031
`
`NDA 208658/S-017
`
`
`
`SUPPLEMENT APPROVAL
`
`
`Boehringer Ingelheim Pharmaceuticals, Inc.
`Attention: Agnieszka Abeyta, Pharm.D.
`Associate Director, Regulatory Affairs
`900 Ridgebury Road, PO Box 368
`Ridgefield, CT 06877
`
`Dear Dr. Abeyta:
`
`Please refer to your supplemental new drug applications (sNDAs) submitted under
`section 505(b) and pursuant to section 505(b)(2) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for the following:
`
`
`
`Application
`Number
`
`NDA 204629
`
`Supplement
`Number
`
`S-034
`
`NDA 206073
`
`S-031
`
`NDA 206111
`
`S-031
`
`NDA 208658
`
`S-017
`
`Product Name
`
`Jardiance (empagliflozin)
`tablets
`Glyxambi (empagliflozin and
`linagliptin) tablets
`Synjardy (empagliflozin and
`metformin hydrochloride)
`tablets
`Synjardy XR (empagliflozin and
`metformin hydrochloride
`extended-release) tablets
`
`Submission and
`Receipt Date
`September 15,
`2021
`September 22,
`
`2021
`September 22,
`
`2021
`
`September 22,
`2021
`
`
`These Prior Approval sNDAs provide for revisions to the Postmarketing Experience
`section of the Prescribing Information of Jardiance, Glyxambi, Synjardy, and Synjardy
`XR to include the adverse reaction constipation.
`
`APPROVAL & LABELING
`
`We have completed our review of these applications, as amended. They are 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
`
`
`Reference ID: 4955647
`
`

`

`NDA 204629/S-034
`NDA 206073/S-031
`NDA 206111/S-031
`
`NDA 208658/S-017
`Page 2
`
`
`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).
`
`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.
`Because none of these criteria apply to your application, you are exempt from this
`requirement.
`
`
`
` 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: 4955647
`
`

`

`NDA 204629/S-034
`NDA 206073/S-031
`NDA 206111/S-031
`
`NDA 208658/S-017
`Page 3
`
`
`
`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 Michael Oyewole, Regulatory Project Manager, at
`(301) 796-3897.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Monika Houstoun, Pharm.D., M.P.H.
`Deputy Director for Safety (Acting)
`Division of Diabetes, Lipid Disorders, and Obesity
`Office of Cardiology, Hematology,
`
`Endocrinology, and Nephrology
`Office of New Drugs
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURES:
`Content of Labeling (Prescribing Information and Medication Guide) for Jardiance,
`Glyxambi, Synjardy, and Synjardy XR
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4955647
`
`

`

`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/
`------------------------------------------------------------
`
`MONIKA A HOUSTOUN
`03/21/2022 03:25:02 PM
`
`I
`
`Reference ID: 4955647
`
`(
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`
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