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Vyjuvek
beremagene geperpavec-svdt
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Vyjuvek
Proper name
beremagene geperpavec-svdt
Licence type
351(a)
BLA number
125774
Applicant
Krystal Biotech, Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 5.0x10^9 PFU/mL | Gel | Topical | Single-Dose Vial | Rx | May 19, 2023 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | September 12, 1932 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |