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).

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.