QUVIVIQ
ITEM | DESCRIPTION |
SPONSOR/HOLDER | IDORSIA PHARMACEUTICALS LTD |
Application No. | #214985 |
Application Type | NDA |
Active Ingredient | Daridorexant |
Dosage Form | TABLET |
Route of Administration | ORAL |
Strengths | EQ 25mg Base |
Indication for Use | Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance |
Approval Date | 07/01/2022 |
CIBINQO
ITEM | DESCRIPTION |
SPONSOR/HOLDER | PFIZER INC |
Application No. | #213871 |
Application Type | NDA |
Active Ingredient | Abrocitinib |
Dosage Form | TABLET |
Route of Administration | ORAL |
Strengths | 50mg; 100mg; 200mg |
Indication for Use | To treat refractory, moderate-to-severe atopic dermatitis |
Approval Date | 14/01/2022 |
KIMMTRAK
ITEM | DESCRIPTION |
SPONSOR/HOLDER | IMMUNOCORE LTD |
Application No. | #761228 |
Application Type | BLA |
Active Ingredient | Tebentafusp-tebn |
Dosage Form | INJECTABLE |
Route of Administration | INJECTION |
Strengths | N/a |
Indication for Use | To treat unresectable or metastatic uveal melanoma |
Approval Date | 25/01/2022 |
VABYSMO
ITEM | DESCRIPTION |
SPONSOR/HOLDER | GENENTECH INC |
Application No. | #761235 |
Application Type | BLA |
Active Ingredient | Faricimab-svoa |
Dosage Form | INJECTABLE |
Route of Administration | INTRAVITREAL |
Strengths | N/a |
Indication for Use | To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema |
Approval Date | 28/01/2022 |