BioMarin Pharmaceutical Inc. (BMRN)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| BLA761079 - BIOMARIN PHARM | |||||||
| PALYNZIQ | PEGVALIASE-PQPZ | INJECTABLE;INJECTION | 2.5MG/O.5ML | Prescription | |||
| PALYNZIQ | PEGVALIASE-PQPZ | INJECTABLE;INJECTION | 10MG/0.5ML | Prescription | |||
| PALYNZIQ | PEGVALIASE-PQPZ | INJECTABLE;INJECTION | 20MG/ML | Prescription | |||
| BLA761052 - BIOMARIN PHARM | |||||||
| BRINEURA | CERLIPONASE ALFA | INJECTABLE;INJECTION | 30MG/ML | Prescription | |||
| NDA214938 - BIOMARIN PHARM | |||||||
| VOXZOGO | VOSORITIDE | POWDER;SUBCUTANEOUS | 0.56MG/VIAL | Prescription | |||
| VOXZOGO | VOSORITIDE | POWDER;SUBCUTANEOUS | 1.2MG/VIAL | Prescription | |||
| VOXZOGO | VOSORITIDE | POWDER;SUBCUTANEOUS | 0.4MG/VIAL | Prescription | |||
| NDA205065 - BIOMARIN PHARM | |||||||
| KUVAN | SAPROPTERIN DIHYDROCHLORIDE | POWDER;ORAL | 100MG/PACKET | Prescription | |||
| KUVAN | SAPROPTERIN DIHYDROCHLORIDE | POWDER;ORAL | 500MG/PACKET | Prescription | |||
| BLA125460 - BIOMARIN PHARM | |||||||
| VIMIZIM | ELOSULFASE ALFA | INJECTABLE;INJECTION | 5MG/5ML | Prescription | |||
| NDA022181 - BIOMARIN PHARM | |||||||
| KUVAN | SAPROPTERIN DIHYDROCHLORIDE | TABLET;ORAL | 100MG | Prescription | |||