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Winrevair
sotatercept-csrk
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Winrevair
Proper name
sotatercept-csrk
Licence type
351(a)
BLA number
761363
Applicant
Merck Sharp & Dohme LLC
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 45MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | March 26, 2024 |
| 60MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | March 26, 2024 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | March 26, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |