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Vowst

fecal microbiota spores, live-brpk

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Vowst

Proper name

fecal microbiota spores, live-brpk

Licence type

351(a)

BLA number

125757

Applicant

Aimmune Therapeutics, Inc.

Center

CBER

Presentations

First licensure

April 26, 2023

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1X10 LOG 6 AND 3X10 LOG 7CFU/TAB	Capsule	Oral	Bottle	Rx	April 26, 2023

Source: Purple Book

Kind	Expires
Orphan exclusivity	April 26, 2030

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