FDA Approval for PONVORY issued to VANDA PHARMS INC
$VNDA
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 213498
Company: VANDA PHARMS INC
Company: VANDA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PONVORY | PONESIMOD | 2MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| PONVORY | PONESIMOD | 3MG | TABLET;ORAL | Prescription | None | Yes | No |
| PONVORY | PONESIMOD | 4MG | TABLET;ORAL | Prescription | None | Yes | No |
| PONVORY | PONESIMOD | 5MG | TABLET;ORAL | Prescription | None | Yes | No |
| PONVORY | PONESIMOD | 6MG | TABLET;ORAL | Prescription | None | Yes | No |
| PONVORY | PONESIMOD | 7MG | TABLET;ORAL | Prescription | None | Yes | No |
| PONVORY | PONESIMOD | 8MG | TABLET;ORAL | Prescription | None | Yes | No |
| PONVORY | PONESIMOD | 9MG | TABLET;ORAL | Prescription | None | Yes | No |
| PONVORY | PONESIMOD | 10MG | TABLET;ORAL | Prescription | None | Yes | No |
| PONVORY | PONESIMOD | 20MG | TABLET;ORAL | Prescription | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 03/18/2021 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213498Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213498Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/05/2024 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213498s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213498Orig1s005,s006ltr.pdf | |
| 06/05/2024 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213498s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213498Orig1s005,s006ltr.pdf | |
| 08/10/2023 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213498s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213498Orig1s004ltr.pdf | |
| 10/28/2021 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213498Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/05/2024 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213498s005s006lbl.pdf | |
| 06/05/2024 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213498s005s006lbl.pdf | |
| 08/10/2023 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213498s004lbl.pdf | |
| 10/28/2021 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s001lbl.pdf | |
| 10/28/2021 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s001lbl.pdf | |
| 03/18/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s000lbl.pdf |