Liraglutide: Regulatory Status
Current legal and regulatory status for Liraglutide across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to Liraglutide overviewUnited States
FDA Approved
Prescription required
Recent Regulatory Action
Generic liraglutide injection approved by FDA (December 2024).
FDA-approved as Victoza (T2D, 2010) and Saxenda (chronic weight management, 2014). First GLP-1 RA with demonstrated cardiovascular benefit (LEADER trial). Generic versions available since December 2024.
What This Means
Reclassification is not the same as FDA approval.
Even if Liraglutide moves to Category 1, it remains an off-label therapeutic that requires physician supervision. Category 1 means it can be compounded under section 503A — it does not confer approved-drug status.