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FDA Drug/Biologics Approval BLA 125293, PEGLOTICASE
FDA Drug/Biologics Approval BLA 125293, PEGLOTICASE
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BLA 125293
Company: HORIZON PHARMA
Drug Name: KRYSTEXXA
Active Ingredients: PEGLOTICASE
Strength: 8MG
Dosage Form/Route: INJECTABLE; INJECTION
Action Date: 09/14/2010
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: HORIZON PHARMA
Drug Name: KRYSTEXXA
Active Ingredients: PEGLOTICASE
Strength: 8MG
Dosage Form/Route: INJECTABLE; INJECTION
Action Date: 09/14/2010
Marketing Status: Prescription
Submission Classification: ORIG-1
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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