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Myalept
metreleptin
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Myalept
Proper name
metreleptin
Licence type
351(a)
BLA number
125390
Applicant
Chiesi Farmaceutici S.p.A.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 11.3MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | February 24, 2014 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | February 24, 2021 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |