General MedicationsSUBCUTANEOUSStandard
ADLYXIN
LIXISENATIDE
Standard Dose
0.3MG/3ML (0.1MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ADLYXIN is listed in Drugs@FDA under application 208471 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LIXISENATIDE Form and strength SOLUTION;SUBCUTANEOUS - 0.3MG/3ML (0.1MG/ML) Sponsor SANOFI-AVENTIS US Submission history Latest submission status date: 2026-03-12 00:00:00.
Structured Monograph
Clinical summary
Approval overview ADLYXIN is listed in Drugs@FDA under application 208471 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient LIXISENATIDE Form and strength SOLUTION;SUBCUTANEOUS - 0.3MG/3ML (0.1MG/ML) Sponsor SANOFI-AVENTIS US Submission history Latest submission status date: 2026-03-12 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.