Product Details for: Avlayah
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
150MG
Single-Dose Vial
351(a)
Avlayah
Rx
Proper Name
tividenofusp alfa-eknm
tividenofusp alfa-eknm
BLA Number
761485
761485
Applicant
Denali Therapeutics Inc.
Denali Therapeutics Inc.
Original Approval Date
March 24, 2026
March 24, 2026
Date of First Licensure