New drug approvals - December 2021

  • Please click here for a list of summary reports of benefit-risk assessments.

Product Name

NUFILONG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 6MG/0.6ML

Active Ingredient

Pegfilgrastim

Application type

NDA-2: Biosimilar

Product Registrant

PHARMA TO MARKET PTE. LTD

Date of Approval

07/12/2021

Registration No.

SIN16393P

Indications:

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in

patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic

myeloid leukaemia and myelodysplastic syndromes).

Product Name

COMIRNATY DISPERSION FOR INJECTION 30MCG/DOSE

COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION 10MCG/DOSE

Active Ingredient

Tozinameran

Application type

NDA-1/2: New biological entity

Product Registrant

BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE LTD

Date of Approval

10/12/2021

Registration No.

SIN16396P, SIN16397P

Indications:

COMIRNATY is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 5 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

 

Product Name

ONCASPAR POWDER FOR SOLUTION FOR INJECTION / INFUSION 750 U/ML

Active Ingredient

Pegaspargase

Application type

NDA-1: New biological entity

Product Registrant

SERVIER (S) PTE LTD

Date of Approval

27/12/2021

Registration No.

SIN16408P

Indications:

Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL).

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals