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Lartruvo
olaratumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Lartruvo
Proper name
olaratumab
Licence type
351(a)
BLA number
761038
Applicant
Eli Lilly and Company
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 190MG/19ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Disc | July 10, 2017 |
| 500MG/50ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Disc | October 19, 2016 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | February 25, 2020 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |