FDA Approval for VYALEV issued to ABBVIE INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 216962
Company: ABBVIE INC
Company: ABBVIE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VYALEV | FOSCARBIDOPA AND FOSLEVODOPA | 12MG/240MG / ML | INJECTION;SOLUTION | Prescription | None | No | No |
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 |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216962Orig1s000ltr.pdf |