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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216962
Company: ABBVIE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VYALEV FOSCARBIDOPA; FOSLEVODOPA 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/16/2024 ORIG-1 Approval Type 3 - New Dosage Form and Type 4 - New Combination STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216962s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216962Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/216962Orig1s000TOC.html

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/16/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216962s000lbl.pdf
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