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Drug Approval Package: PALYNZIQ (pegvaliase-pqpz)

Company: BioMarin Pharmaceutical Inc.
Application Number: 761079
Approval Date: 05/24/2018

Drugs@FDA information available about PALYNZIQ

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

FDA Approval Letter and Labeling

Approval Letter(s) (PDF)
Printed Labeling (PDF)

FDA Application Review Files

REMS (PDF)
Multi-Discipline Review/Summary, Clinical, Non-Clinical (PDF)
Officer/Employee List (PDF)
Chemistry Review(s) (PDF)
Risk Assessment and Risk Mitigation Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: June 28, 2018

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.

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