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Lenmeldy

atidarsagene autotemcel

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Lenmeldy

Proper name

atidarsagene autotemcel

Licence type

351(a)

BLA number

125758

Applicant

Orchard Therapeutics (Europe) Ltd.

Center

CBER

Presentations

First licensure

March 18, 2024

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
2 x 10^6 to 11.8 x 10^6CELL/ML	Suspension	Intravenous	Bag	Rx	March 18, 2024

Source: Purple Book

Kind	Expires
Orphan exclusivity	March 18, 1931

Purple Book	FDA	Licence type, presentations, reference product, exclusivity