Approval Package for - NDA 215256/S-011 - Wegovy (semaglutide)

Sep 27, 2026

Uploaded by Cipher

Approval Package for application number 215256Orig1s011 covers FDA review and approval of Wegovy (semaglutide) injection. The supplemental approval adds an additional indication to the Prescribing Information and revises the Medication Guide. Wegovy is indicated with a reduced calorie diet and increased physical activity to reduce risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. The package also fulfills related postmarketing requirement commitments and includes administrative approval, labeling content submissions in SPL format, and pediatric assessment obligations under PREA.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages300

Reading Time12 h 36 min

AccessFree to download

Approval Letter

Supplement Approval (NDA 215256/S-011)

Fulfillment of Postmarketing Requirement(s)

Approval & Labeling

Waiver of 1/2 Page Length Requirement for Highlights

Content of Labeling

Required Pediatric Assessments

CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 215256Orig1s011 Trade Name: WEGOVY Generic or Proper semaglutide Name: Sponsor: Novo Nordisk Inc. Approval Date: March 8, 2024 Indication: WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight. • to reduce excess body weight and maintain weight reduction long term in: • Adults and pediatric patients aged 12 years and older with obesity • Adults with overweight in the presence of at least one weight-related comorbid condition. CENTER FOR DRUG EVALUATION AND RESEARCH 215256Orig1s011 CONTENTS Reviews / Information Included in this NDA Review. | Approval Letter | X | | --- | --- | | Other Action Letters | | | Labeling | X | | REMS | | | Summary Review | | | Officer/Employee List | | | Office Director Memo | | | Cross Discipline Team Leader Review | | | Clinical Review(s) | X | | Product Quality Review(s) | | | Non-Clinical Review(s) | | | Statistical Review(s) | X | | Clinical Microbiology / Virology Review(s) | | | Clinical Pharmacology Review(s) | | | Other Reviews | X | | Risk Assessment and Risk Mitigation Review(s) | | | Proprietary Name Review(s) | | | Administrative/Correspondence Document(s) | | CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 215256Orig1s011 APPROVAL LETTER NDA 215256/S-011 SUPPLEMENT APPROVAL FULFILLMENT OF POSTMARKETING REQUIREMENT(S) Novo Nordisk Inc. Attention: Stephanie DeChiaro Executive Director, Regulatory Affairs P.O. Box 846 800 Scudders Mill Road Plainsboro, NJ 08536 Dear Stephanie DeChiaro: Please refer to your supplemental new drug application (sNDA) dated and received September 8, 2023 , and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Wegovy (semaglutide) injection. This Prior Approval sNDA provides for the addition of the following indication to the Prescribing Information , with corresponding revisions to the Medication Guide: • Wegovy is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight. The addition of this indication is based on the result from trial EX9536-4388 , entitled“SELECT − Semaglutide effects on cardiovascular outcomes in people with overweight or obesity.” This trial also addresses the following postmarketing requirement listed in the June 4, 2021 , approval letter: 4081-6: Complete the ongoing randomized, double-blind, parallel-group, placebo-controlled trial in approximately 17,500 patients with established CV disease and overweight or obesity (randomized 1:1 to semaglutide 2.4 mg and placebo) to evaluate the long-term effects of semaglutide 2.4 mg on pancreatitis, gallbladder disorders, renal safety, serious hepatic events, malignant neoplasms, serious hypoglycemia, and serious gastrointestinal disorders. APPROVAL & LABELING NDA 215256/S-011 Page 2 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 labeling with minor editorial revisions listed below and reflected in the enclosed labeling. • A vertical line has been added to the left edge of the indication statements. WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS 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 Pres

FAQs

What supplemental indication was added for Wegovy (semaglutide) injection?

Wegovy was indicated, with a reduced calorie diet and increased physical activity, to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight.

Which trial supported the added indication?

The indication addition was based on trial EX9536-4388 titled “SELECT - Semaglutide effects on cardiovascular outcomes in people with overweight or obesity.”

What labeling and submission steps were required after approval?

Within 14 days, the sponsor must submit content of labeling in structured product labeling (SPL) format via eLIST and amend pending supplemental applications with labeling changes, including providing highlighted or marked-up and clean Word versions.

Sep 27, 2026

Uploaded by Cipher