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Nucala
mepolizumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Nucala
Proper name
mepolizumab
Licence type
351(a)
BLA number
125526
Applicant
GlaxoSmithKline LLC
Center
CDER
Presentations
8
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | November 4, 2015 |
| 100MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | June 6, 2019 |
| 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | June 6, 2019 |
| 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | June 6, 2019 |
| 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | June 6, 2019 |
| 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | June 6, 2019 |
| 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 22, 2022 |
| 40MG/0.4ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 22, 2022 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | September 25, 2027 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |