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` NDA 217806/S-003
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` CORRECTED SUPPLEMENT APPROVAL
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`Eli Lilly and Company
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`Attention: Ingrid Hensley, PhD
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`Executive Director, Global Regulatory Affairs –- North America
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`Lilly Corporate Center
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`Drop Code 2543
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`Indianapolis, IN 46285
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`Dear Dr. Hensley:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`November 20, 2023, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Zepbound (tirzepatide) injection.
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`We also refer to our approval letter dated March 28, 2024, which contained the following
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`error: the approval letter included “Medication Guide
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`previously approved November 8, 2023)” in the Enclosures list and enclosure. This
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`Medication Guide is superceded by the Medication Guide dated March 2024 which
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`includes single-dose pen and single-dose vial.
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`This corrected action letter incorporates the correction of the error. The effective action
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`date will remain March 28, 2024, the date of the original letter.
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`This Prior Approval sNDA provides for the addition of a single-dose vial container
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`closure system for tirzepatide drug product manufactured at
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` and for the expansion of testing role of
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`quality control testing site for tirzepatide single-dose vial presentation.
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`APPROVAL & LABELING
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`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
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`labeling.
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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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`the
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`Reference ID: 5357157
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`(b) (4)
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`(b) (4)
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`(b) (4)
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`(b) (4)
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` NDA 217806/S-003
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` 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, Instructions for Use, and Medication Guide), with the addition of
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`any labeling changes in pending “Changes Being Effected” (CBE) supplements, as well
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`as annual 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
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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
`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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`CARTON AND CONTAINER LABELING
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`Submit final printed carton and container labeling that are identical to the enclosed
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`carton and container labeling, as soon as they are available, but no more than 30 days
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`after they are printed. Please submit these labeling electronically according to the
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`guidance for industry Providing Regulatory Submissions in Electronic Format — Certain
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`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications. For administrative purposes, designate this submission “Final Printed
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`Carton and Container Labeling for approved NDA 217806/S-003.” Approval of this
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`submission by FDA is not required before the labeling is used.
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`PATENT LISTING REQUIREMENTS
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`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
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`submitted in a supplement require you to submit patent information for listing in the
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`Orange Book upon approval of the supplement. You must submit the patent information
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`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
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` 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
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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: 5357157
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` NDA 217806/S-003
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` Page 3
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` applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
` supplement for the patent information to be timely filed (see 21 CFR
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` 314.53(c)(2)(ii)). You also must ensure that any changes to your approved NDA that
` require the submission of a request to remove patent information from the Orange Book
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` are submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
` 314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
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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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`Your product is a Part 3 combination product (21 CFR 3.2(e)); therefore, you must also
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`comply with postmarketing safety reporting requirements for an approved combination
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`product (21 CFR 4, Subpart B). Additional information on combination product
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`postmarketing safety reporting is available at FDA.gov.3
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`If you have any questions, call Arati B. Kamath, Ph.D., Regulatory Project Manager, at
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`(301) 796-3159.
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`Sincerely,
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`{See appended electronic signature page}
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`John Sharretts, M.D.
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`Director
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`Division of Diabetes, Lipid Disorders, and Obesity
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`Office of Cardiology, Hematology, Endocrinology,
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`and Nephrology
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`Office of New Drugs
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`• Content of Labeling
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`o Prescribing Information
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`o Medication Guide
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`Instructions for Use- single dose pen (version previously approved
`o
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`November 8, 2023)
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`Instructions for Use- single dose vial
`o
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`• Carton and Container Labeling- single dose vial
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` 3 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-
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` reporting-combination-products
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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: 5357157
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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/
`------------------------------------------------------------
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`JOHN M SHARRETTS
`04/02/2024 01:05:44 PM
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`Reference ID: 5357157
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`(
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