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Drugs@FDA: FDA-Approved Drugs

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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)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214938s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214938Orig1s002ltr.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

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