New drug indication approval - December 2022

Product Name

OTEZLA TABLET STARTER PACK

OTEZLA TABLET 30 MG

Active Ingredient

Apremilast

Product Registrant

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Date of Approval

02/12/2022

Indications:

Otezla is indicated for

· The treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Product Name

IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML

Active Ingredient

Durvalumab

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

12/12/2022

Indications:

IMFINZI in combination with cisplatin and gemcitabine, is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC).

*Evaluated as part of Project Orbis

Product Name

DENGVAXIA POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Active Ingredient

CYD dengue virus serotype 1

CYD dengue virus serotype 2

CYD dengue virus serotype 3

CYD dengue virus serotype 4

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

13 December 2022

Indications:

Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 12 through 45 years of age with test-confirmed previous dengue infection.