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General MedicationsSUBCUTANEOUSStandard

VYALEV

FOSCARBIDOPA; FOSLEVODOPA

Standard Dose
120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview VYALEV is listed in Drugs@FDA under application 216962 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FOSCARBIDOPA; FOSLEVODOPA Form and strength SOLUTION;SUBCUTANEOUS - 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML) Sponsor ABBVIE Submission history Latest submission status date: 2026-03-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview VYALEV is listed in Drugs@FDA under application 216962 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FOSCARBIDOPA; FOSLEVODOPA Form and strength SOLUTION;SUBCUTANEOUS - 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML) Sponsor ABBVIE Submission history Latest submission status date: 2026-03-19 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.