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FDA Drug/Biologics Approval BLA 125319 S-097, CANAKINUMAB
FDA Drug/Biologics Approval BLA 125319 S-097, CANAKINUMAB
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BLA 125319 S-097
Company: NOVARTIS PHARMS
Drug Name: ILARIS
Active Ingredients: CANAKINUMAB
Strength: 180MG
Dosage Form/Route: INJECTABLE; SUBCUTANEOUS
Action Date: 06/17/2009
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: NOVARTIS PHARMS
Drug Name: ILARIS
Active Ingredients: CANAKINUMAB
Strength: 180MG
Dosage Form/Route: INJECTABLE; SUBCUTANEOUS
Action Date: 06/17/2009
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
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