New drug indication approval - Apr 2021

Product Name

IBRANCE CAPSULE 75MG

IBRANCE CAPSULE 100MG

IBRANCE CAPSULE 125MG

Active Ingredient

Palbociclib

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

06 Apr 2021

Indications:

Ibrance is indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

- an aromatase inhibitor as initial endocrine-based therapy; or

- fulvestrant in patients with disease progression following endocrine therapy.

Product Name

STELARA SOLUTION FOR INJECTION 45 MG/0.5 ML

STELARA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 45 MG/0.5 ML

STELARA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 90 MG/1 ML

Active Ingredient

Ustekinumab

Product Registrant

JOHNSON & JOHNSON PTE LTD

Date of Approval

27/04/2021

Indications:

Pediatric Plaque Psoriasis:

STELARA is indicated for the treatment of pediatric patients (children and adolescents) (6 years and older) with moderate to severe plaque psoriasis who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Product Name

LYNPARZA FILM COATED TABLET 100MG, 150MG

Active Ingredient

Olaparib

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

28 Apr 2021

Indications:

Lynparza in combination with bevacizumab is indicated for the:

• maintenance treatment of adult patients with advanced (FIGO stages III and IV) high grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5.1).