New drug indication approval - March 2022

 

Product Name

INFLUVAC TETRA, SUSPENSION FOR INJECTION IN

PRE-FILLED SYRINGE 0.5 ML

Active Ingredient

Influenza Virus (SH) A/Hong Kong/2671/2019 (H3N2)-like strain (A/Hong Kong/2671/2019, IVR-208);

Influenza Virus (SH) A/Victoria/2570/2019 (H1N1)pdm09- like strain (A/Victoria/2570/2019, IVR-215);

Influenza Virus (SH) B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type);

Influenza Virus (SH) B/Washington/02/2019-like strain (B/Washington/02/2019, wild type)

Product Registrant

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Date of Approval

04/03/2022

Indications:

Prophylaxis of influenza, especially those who run an increased risk of associated complications.

Influvac® Tetra is indicated in adults and children from 6 months of age. The use of Influvac® Tetra should be based on official recommendations.

 

Product Name

DARZALEX SC SOLUTION FOR INJECTION 1800MG/15ML

Active Ingredient

Daratumumab

Product Registrant

JOHNSON & JOHNSON PTE. LTD.

Date of Approval

04/03/2022

Indications:

DARZALEX® SC is indicated for the treatment of patients with multiple myeloma:

- in combination with pomalidomide and dexamethasone in patients who have received one prior therapy including lenalidomide and a proteasome inhibitor (PI) and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a PI and have demonstrated disease progression on or after the last therapy.

 

Product Name

RIXATHON CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/ML

RIXATHON CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/10ML

Active Ingredient

Rituximab

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

04/03/2022

Indications:

RIXATHON in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) inhibitor therapies.

 

Product Name

OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10 MG/ML

Active Ingredient

Nivolumab

Product Registrant

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

Date of Approval

09/03/2022

Indications:

Adjuvant treatment of oesophageal or gastroesophageal junction cancer (OC or GEJC):

OPDIVO as monotherapy is indicated for the adjuvant treatment of completely resected oesophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

*Evaluated as part of Project Orbis

 

Product Name

JARDIANCE FILM COATED TABLET 10MG

Active Ingredient

Empagliflozin

Product Registrant

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Date of Approval

17/03/2022

Indications:

JARDIANCE is indicated in adult patients with heart failure (NYHA class II-IV), with or without type 2 diabetes mellitus to reduce the risk of cardiovascular death and hospitalization for heart failure (see clinical trials).

 

Product Name

BRIDION SOLUTION FOR INJECTION 100MG/ML

Active Ingredient

Sugammadex

Product Registrant

MSD PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

22/03/2022

Indications:

Reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older.

 

Product Name

DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 200 mg/1.14ml, 300 mg/2ml

Active Ingredient

Dupilumab

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

30/03/2022

Indications:

1.2 Asthma

DUPIXENT is indicated in patients 6 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by elevated blood eosinophils and/or elevated FeNO.

DUPIXENT is indicated as maintenance therapy for oral corticosteroid-dependent asthma

*Evaluated via Access

 

Product Name

TS-ONE CAPSULE 20 and 25

Active Ingredient

Gimeracil, oteracil potassium and tegafur

Product Registrant

Taiho Pharma Asia Pacific Pte. Ltd.

Date of Approval

30/03/2022

Indications:

For the treatment of locally advanced or metastatic non-small cell lung cancer in patients who have been previously treated with platinum-based chemotherapy

 

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Indication Approvals