Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 214938
Company: BIOMARIN PHARM
Company: BIOMARIN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VOXZOGO | VOSORITIDE | 0.4MG/VIAL | POWDER;SUBCUTANEOUS | Prescription | None | Yes | Yes |
| VOXZOGO | VOSORITIDE | 0.56MG/VIAL | POWDER;SUBCUTANEOUS | Prescription | None | Yes | Yes |
| VOXZOGO | VOSORITIDE | 1.2MG/VIAL | POWDER;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 |
|---|---|---|---|---|---|---|---|
| 11/19/2021 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214938Orig1s000Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214938Orig1s000Corrected_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214938Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/19/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214938Orig1s000Corrected_lbl.pdf |