(~ II U.S. FOOD & DRUG
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`\,,.,.,~~
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`ADMINIS T RAT I O N
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` NDA 022044/S-051
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` SUPPLEMENT APPROVAL
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` Merck Sharp & Dohme Corp.,
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` a subsidiary of Merck & Co., Inc.
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` Attention: Lou Ann Eader, PhD
` Director, Global Regulatory Affairs
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` 351 N. Sumneytown Pike, P. O. Box 1000
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` UG2D-44
` North Wales, PA 19454
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` Dear Dr. Eader:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received
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` June 1, 2021, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
` Act (FDCA) for Janumet (sitagliptin and metformin hydrochloride) tablets.
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`This “Changes Being Effected” supplemental new drug application provides for
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` correction of the salt equivalency statement for metformin HCl in Section 11 of the
`package insert in response to FDA’s Supplement Request letter dated May 04, 2021.
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` APPROVAL & LABELING
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` We have completed our review of this supplemental application. It is approved,
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` effective on the date of this letter, for use as recommended in the agreed-upon labeling
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` and with minor editorial revisions listed below and reflected in the enclosed labeling.
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`The revision date listed at the end of the Highlights of Prescribing Information has been
`updated to “11/2021.”
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` CONTENT OF LABELING
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` 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 MS Word format,
` that includes the changes approved in this supplemental application, as well as annual
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`reportable changes, and annotate each change. To facilitate review of your submission,
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` 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,
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`including supplement number(s) and annual report date(s).
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` U.S. Food & Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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` NDA 022044/S-051
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` Page 2
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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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` set forth under 21 CFR 314.80 and 314.81.
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`If you have any questions, call Christopher LaFleur, Regulatory Business Process
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` Manager, at (240) 402 - 4724.
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` Sincerely,
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` {See appended electronic signature page}
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` Ramesh Raghavachari, Ph.D.
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` Chief, Branch 1
` Division of Post-Marketing Activities I
` Office of Lifecycle Drug Products
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` Office of Pharmaceutical Quality
` Center for Drug Evaluation and Research
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` Enclosure:
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` Content of Labeling
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` U.S. Food & 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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`Ramesh
`Raghavachari
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`Digitally signed by Ramesh Raghavachari
`Date: 11/04/2021 03:29:11PM
`GUID: 502d0913000029f375128b0de8c50020
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