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` NDA 209805/S-005
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`SUPPLEMENT APPROVAL
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` Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
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` Attention: Vivian Fuh, M.D., F.A.C.P.
` Executive Director, Global Regulatory Affairs
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` 126 E. Lincoln Avenue, P.O. Box 2000
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` Mail Drop: RY34-B188
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` Rahway, NJ 07065
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`Dear Dr. Fuh:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`June 18, 2019, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Steglujan (ertugliflozin and sitagliptin) tablets.
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`We also refer to our letter dated May 3, 2019, notifying you, under Section 505(o)(4) of
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`the FDCA, of new safety information that we believe should be included in the labeling
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`for dipeptidyl peptidase-4 (DPP-4) inhibitors, including Steglujan. This information
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`pertains to the risk of rhabdomyolysis.
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`This supplemental new drug application provides for revisions to the labeling for
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`Steglujan, consistent with our May 3, 2019, letter.
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`APPROVAL & LABELING
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`We have completed our review of this application. It is approved, effective on the date of
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`this letter, for use as recommended in the enclosed agreed-upon labeling with minor
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`editorial revisions listed below and reflected in the enclosed labeling.
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`•
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`Included a page break between the Highlights of Prescribing Information and the
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`Full Prescribing Information Contents
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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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`Reference ID: 4456150
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` NDA 209805/S-005
` Page 2
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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
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` FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information and Medication Guide), with the addition of any labeling
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`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`reportable changes not included in the enclosed labeling. If the content of labeling in
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`SPL format initially submitted with this CBE-0 labeling supplement is identical to the
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`attached approved labeling, an additional submission of content of labeling in SPL
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`format is not required.
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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
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`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
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`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
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`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
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this
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`requirement.
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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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
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`www.fda.gov
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`Reference ID: 4456150
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` NDA 209805/S-005
` Page 3
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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 Liz Godwin, Senior Regulatory Project Manager, at
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`240-402-3438.
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`Sincerely,
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`{See appended electronic signature page}
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`William Chong, M.D.
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`Deputy Director (Acting)
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`Division of Metabolism and Endocrinology
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`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
`o Prescribing Information
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`o Medication Guide (version approved October 26, 2018)
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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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`Reference ID: 4456150
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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.
`--------------------------------------------------------------------------------------------
`/s/
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`WILLIAM H CHONG
`07/01/2019 08:18:44 AM
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`Reference ID: 4456150
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