New drug indication approval - January 2024

Product Name

VOCABRIA FILM-COATED TABLETS 30MG,
VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 600 MG/3 ML,
VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 400 MG/ 2 ML

Active Ingredient (Strength)

Cabotegravir Sodium eqv Cabotegravir(30mg),
Cabotegravir(200mg/ml),
Cabotegravir(200 mg/ml)

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

20/01/2024

Indications:

Film-coated Tablets:
VOCABRIA tablets are indicated in combination with rilpivirine tablets for short term (see Dosage and Administration) treatment of human immunodeficiency virus (HIV)-1 infection in adults who are virologically suppressed (HIV-1 RNA without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class):
· oral lead-in to assess tolerability of cabotegravir prior to administration of long
acting (LA) VOCABRIA injection.
· oral therapy for adults who will miss planned dosing with VOCABRIA injection.

Suspension for Injection:
VOCABRIA injection is indicated in combination with rilpivirine injection for treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA
antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class (see Clinical studies).

Product Name

CIBINQO FILM-COATED TABLET 50 MG,
CIBINQO FILM-COATED TABLET 100 MG,
CIBINQO FILM-COATED TABLET 200 MG

Active Ingredient (Strength)

Abrocitinib(50.00 mg),
Abrocitinib(100.00 mg),
Abrocitinib(200.00 mg)

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

12/01/2024

Indications:

CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents (age 12 years and above) who are candidates for systemic therapy and whose disease is not adequately controlled with topical medications or for whom topical treatments are otherwise medically inadvisable.