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FDA Drug/Biologics Approval BLA 125561, SEBELIPASE ALFA
FDA Drug/Biologics Approval BLA 125561, SEBELIPASE ALFA
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BLA 125561
Company: ALEXION PHARM
Drug Name: KANUMA
Active Ingredients: SEBELIPASE ALFA
Strength: 20MG/10ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 12/08/2015
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: ALEXION PHARM
Drug Name: KANUMA
Active Ingredients: SEBELIPASE ALFA
Strength: 20MG/10ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 12/08/2015
Marketing Status: Prescription
Submission Classification: ORIG-1
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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