New drug indication approval - May 2024

For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.

Product NameTRODELVY POWDER FOR SOLUTION FOR INFUSION 180MG/VIAL
Active Ingredient (Strength) Sacituzumab govitecan(180mg/vial)
Product Registrant GILEAD SCIENCES SINGAPORE PTE LTD
Date of Approval 24/05/2024
Indications:
TRODELVY is indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

 

Product NameOTEZLA TABLET STARTER PACK,
OTEZLA TABLET 30 MG
Active Ingredient (Strength) APREMILAST (in Beige Tablet)(30 mg), APREMILAST (in Brown Tablet)(20 mg), APREMILAST (in Pink Tablet)(10 mg), Apremilast(30 mg)
Product Registrant AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD
Date of Approval 21/05/2024
Indications:
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease who are candidates for systemic therapy.

 

Product NameYULAREB FILM-COATED TABLET 50MG,
YULAREB FILM-COATED TABLET 150MG,
YULAREB FILM-COATED TABLET 100MG
Active Ingredient (Strength) Abemaciclib(50mg),
Abemaciclib(150.0mg),
Abemaciclib(100.0mg)
Product Registrant DKSH SINGAPORE PTE. LTD.
Date of Approval 28/05/2024

Indications:
1.1 Early Breast Cancer
Yulareb (abemaciclib) in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node-positive early breast cancer at high risk of recurrence (see section 14.1).

1.2 Advanced or Metastatic Breast Cancer
Yulareb (abemaciclib) is indicated:
• in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
• in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

 

Product NameVERZENIO FILM-COATED TABLET 50MG,
VERZENIO FILM-COATED TABLET 100MG,
VERZENIO FILM-COATED TABLET 150MG
Active Ingredient (Strength) Abemaciclib(50.00mg),
Abemaciclib(100.0mg),
Abemaciclib(150.0mg)
Product Registrant DKSH SINGAPORE PTE. LTD.
Date of Approval 28/05/2024
Indications:
Early Breast Cancer
Verzenio (abemaciclib) in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node-positive early breast cancer at high risk of recurrence (see section 14.1).

Advanced or Metastatic Breast Cancer
Verzenio (abemaciclib) is indicated:
• in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
• in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

 

Product NameAPEXXNAR SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML
Active Ingredient (Strength) CRM197 protein(Approx. 51 μg/0.5ml),Pneumococcal polysaccharide serotype 1 (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 10A (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 11A (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 12F (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 14 (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 15B (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 18C (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 19A (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 19F (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 22F (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 23F (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 3 (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 33F (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 4 (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 5 (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 6A (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 6B (conjugate)(4.4 μg/0.5ml),Pneumococcal polysaccharide serotype 7F (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 8 (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 9V (conjugate)(2.2 μg/0.5ml)
Product Registrant PFIZER PRIVATE LIMITED
Date of Approval 16/05/2024
Indications:
Active immunisation for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants, children, and adolescents from 6 weeks to less than 18 years of age.

 

 

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Indication Approvals