semaglutide
Marketed as WEGOVY.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| NDA218316 | WEGOVY | 2025-12-22 | NOVO |
| NDA215256 | WEGOVY | 2021-06-04 | NOVO |
Manufacturers
NOVO
Common denial patterns
- Weight-loss exclusion (Wegovy)
- Step therapy requiring oral semaglutide before injectable
- BMI threshold above FDA label
- Non-formulary tier 4 specialty
Specific notes
Sold as Ozempic (T2D), Wegovy (weight loss + CV risk reduction), Rybelsus (oral T2D). Wegovy received FDA CV indication January 2024 based on SELECT trial.
NovoCare: https://www.novocare.com
Frequently asked questions
Why does insurance commonly deny semaglutide?
Weight-loss exclusion (Wegovy); Step therapy requiring oral semaglutide before injectable; BMI threshold above FDA label; Non-formulary tier 4 specialty.
When was semaglutide FDA approved?
Earliest FDA approval on record: 2021-06-04.
What brand names are sold as semaglutide?
WEGOVY.
Is there a patient assistance program for semaglutide?
Yes — NovoCare at https://www.novocare.com.
What's specific to semaglutide?
Sold as Ozempic (T2D), Wegovy (weight loss + CV risk reduction), Rybelsus (oral T2D). Wegovy received FDA CV indication January 2024 based on SELECT trial.
Related
Sources
Appeal a semaglutide denial
Upload your denial — DenialHelp drafts a physician-ready appeal letter in five minutes with the right clinical guideline and federal regulation cited. $39 first-level, money back if we can't draft a strong appeal.
Get started →Contact: hello@denialhelp.com