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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761079
Company: BIOMARIN PHARM

Medication Guide

REMS

Products on BLA 761079

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PALYNZIQ	PEGVALIASE-PQPZ	2.5MG/O.5ML	INJECTABLE;INJECTION	Prescription	None	No	No
PALYNZIQ	PEGVALIASE-PQPZ	10MG/0.5ML	INJECTABLE;INJECTION	Prescription	None	No	No
PALYNZIQ	PEGVALIASE-PQPZ	20MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761079

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2018	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761079Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761079Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/09/2023	SUPPL-25	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761079Orig1s025ltr.pdf
11/20/2020	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761079s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761079Orig1s010ltr.pdf
10/06/2020	SUPPL-7	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761079Orig1s005,s006,s007ltr.pdf
10/06/2020	SUPPL-6	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761079Orig1s005,s006,s007ltr.pdf
10/06/2020	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761079s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761079Orig1s005,s006,s007ltr.pdf

Labels for BLA 761079

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/20/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761079s010lbl.pdf
10/06/2020	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761079s005lbl.pdf
05/24/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf

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