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`ADMINISTRATION
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`•,.,_;::JJ-
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`NDA 208026/S-020
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` SUPPLEMENT APPROVAL
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`Boehringer Ingelheim Pharmaceuticals, Inc.
` Attention: Agnieszka Abeyta, Pharm.D.
`
`
` Associate Director, Regulatory Affairs
`
` 900 Ridgebury Road
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` PO Box 368
`Ridgefield, CT 06877
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`Dear Dr. Abeyta:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`March 31, 2021, and your amendments, submitted under section 505(b) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for Jentadueto XR (linagliptin and metformin
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`hydrochloride extended-release) tablets.
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`This Prior Approval sNDA provides for revisions to the Jentadueto XR Prescribing
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`Information and Medication Guide to remove information pertaining to incompletely
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`dissolved tablets being eliminated in the feces and update the labeling to conform with
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`current labeling practices.
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon labeling
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`with minor editorial revisions listed below and reflected in the enclosed labeling.
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`(cid:120) Revision dates updated in the Prescribing Information and Medication Guide to
`reflect supplement approval date.
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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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`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
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 4865976
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` NDA 208026/S-020
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` Page 2
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`Prescribing Information and Medication Guide), with the addition of any labeling
`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`reportable changes not included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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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 for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
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`annual reportable changes. To facilitate review of your submission(s), provide a
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`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
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`supplement number(s) and annual report date(s).
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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
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`new active ingredients (which includes new salts and new fixed combinations), new
`indications, new dosage forms, new dosing regimens, or new routes of administration
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`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.
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`Because none of these criteria apply to your application, you are exempt from this
`requirement.
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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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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`U.S. Food and Drug Administration
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`
`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4865976
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`NDA 208026/S-020
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`Page 3
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`If you have any questions, contact Michael Oyewole, Regulatory Project Manager, at
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`(301) 796-3897.
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`Sincerely,
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`{See appended electronic signature page}
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`
`Patrick Archdeacon, M.D.
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`Associate Director for Therapeutics
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`Division of Diabetes, Lipid Disorders, and Obesity
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`Office of Cardiology, Hematology, Endocrinology,
`and Nephrology
`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`(cid:120) Content of Labeling
`o Prescribing Information
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`o Medication Guide
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`
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`Reference ID: 4865976
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`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/
`------------------------------------------------------------
`
`PATRICK ARCHDEACON
`10/01/2021 11:02:45 AM
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`Reference ID: 4865976
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`