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FDA Drug/Biologics Approval BLA 761269 S-001, LECANEMAB-IRMB
FDA Drug/Biologics Approval BLA 761269 S-001, LECANEMAB-IRMB
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BLA 761269 S-001
Company: EISAI INC
Drug Name: LEQEMBI
Active Ingredients: LECANEMAB-IRMB
Strength: 200MG/2ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 01/06/2023
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: EISAI INC
Drug Name: LEQEMBI
Active Ingredients: LECANEMAB-IRMB
Strength: 200MG/2ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 01/06/2023
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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