Biogen Inc. (BIIB)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
| Application | Product Name | Active Ingredient | Form | Strength | Status | ||
|---|---|---|---|---|---|---|---|
| BLA761354 - BIOGEN MA | |||||||
| TOFIDENCE | TOCILIZUMAB-BAVI | INJECTABLE;INJECTION | 80MG/4ML | Prescription | |||
| TOFIDENCE | TOCILIZUMAB-BAVI | INJECTABLE;INJECTION | 200MG/10ML | Prescription | |||
| TOFIDENCE | TOCILIZUMAB-BAVI | INJECTABLE;INJECTION | 400MG/20ML | Prescription | |||
| BLA761178 - BIOGEN INC | |||||||
| ADUHELM | ADUCANUMAB-AVWA | INJECTABLE;INJECTION | 170MG/1.7ML (100MG/ML) | Prescription | |||
| ADUHELM | ADUCANUMAB-AVWA | INJECTABLE;INJECTION | 300MG/3ML (100MG/ML) | Prescription | |||
| BLA761029 - BIOGEN | |||||||
| ZINBRYTA | DACLIZUMAB | INJECTABLE;INJECTION | 150MG/ML | Prescription | |||
| NDA217369 - BIOGEN INC | |||||||
| ZURZUVAE | ZURANOLONE | CAPSULE;ORAL | 30MG | Prescription | |||
| ZURZUVAE | ZURANOLONE | CAPSULE;ORAL | 20MG | Prescription | |||
| ZURZUVAE | ZURANOLONE | CAPSULE;ORAL | 25MG | Prescription | |||
| NDA215887 - BIOGEN MA | |||||||
| QALSODY | TOFERSEN | SOLUTION;INTRATHECAL | 100MG/15ML (6.7MG/ML) | Prescription | |||
| NDA211855 - BIOGEN INC | |||||||
| VUMERITY | DIROXIMEL FUMARATE | CAPSULE, DELAYED RELEASE;ORAL | 231MG | Prescription | |||
| NDA209531 - BIOGEN IDEC | |||||||
| SPINRAZA | NUSINERSEN SODIUM | SOLUTION;INTRATHECAL | EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) | Prescription | |||
| NDA204063 - BIOGEN INC | |||||||
| TECFIDERA | DIMETHYL FUMARATE | CAPSULE, DELAYED RELEASE;ORAL | 240MG | Prescription | |||
| TECFIDERA | DIMETHYL FUMARATE | CAPSULE, DELAYED RELEASE;ORAL | 120MG | Prescription | |||
| BLA125499 - BIOGEN IDEC INC | |||||||
| PLEGRIDY | PEGINTERFERON BETA-1A | INJECTABLE;INJECTION | 125MICROGRAMS/0.5ML | Prescription | |||
| BLA125104 - BIOGEN IDEC | |||||||
| TYSABRI | NATALIZUMAB | VIAL; SINGLE-USE | 300MG | Prescription | |||
| BLA103628 - BIOGEN | |||||||
| AVONEX | INTERFERON BETA-1A | VIAL | 30UG/ML | Prescription | |||