FDA Approval for TAVNEOS issued to CHEMOCENTRYX, INC.
$CCXI
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 214487
Company: CHEMOCENTRYX, INC.
Company: CHEMOCENTRYX, INC.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TAVNEOS | AVACOPAN | 10MG | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/07/2021 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214487s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214487Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/07/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214487s000lbl.pdf |