An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 214938
Company: BIOMARIN PHARM

Products on NDA 214938

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214938

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	STANDARD; 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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2024	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214938s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214938Orig1s004ltr.pdf
10/20/2023	SUPPL-2	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214938s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214938Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/214938Orig1s002.pdf

Labels for NDA 214938

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/04/2024	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214938s004lbl.pdf
10/20/2023	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214938s002lbl.pdf
11/19/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214938Orig1s000Corrected_lbl.pdf

Top