New drug approvals - Feb 2021

Product Name

KESIMPTA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 20MG/0.4ML

KESIMPTA SOLUTION FOR INJECTION IN PRE-FILLED PEN 20MG/0.4ML

Active Ingredient

Ofatumumab

Application type

NDA-1: New biological entity

NDA-2: New strength

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

05/02/2021

Registration No.

SIN16100P, SIN16101P

Indications:

KESIMPTA is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) (refer to Section 12 Clinical Studies).

*Evaluated via Access

Product Name

NUBEQA FILM-COATED TABLET 300MG

Active Ingredient

Darolutamide milled

Application type

NDA-1: New chemical entity

Product Registrant

BAYER (SOUTH EAST ASIA) PTE LTD

Date of Approval

11/02/2021

Registration No.

SIN16103P

Indications:

NUBEQA is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).

Product Name

GENTECH MOLYBDENUM (99Mo) / TECHNETIUM (99mTc) STERILE GENERATOR

Active Ingredient

Sodium pertechnetate (^99mTc)

Application type

NDA-2: New dosage form/indication

Product Registrant

TRANSMEDIC PTE LTD

Date of Approval

24/02/2021

Registration No.

SIN16108P

Indications:

This product is for diagnostic use only.

The eluate from the radionuclide generator (sodium pertechnetate [99mTc] solution for I.V. injection) is indicated for:

• labelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling with such solution

• Thyroid scintigraphy: direct imaging and measurement of thyroid uptake to give information on the size, position, nodularity and function of the gland in case of thyroid disease.

Product Name

VPRIV POWDER FOR SOLUTION FOR INFUSION 400UNITS/VIAL

Active Ingredient

Velaglucerase alfa

Application type

NDA-1: New Chemical Entity

Product Registrant

Takeda Pharmaceuticals (Asia Pacific) Pte Ltd

Date of Approval

24/02/2021

Registration No.

SIN16107P

Indications:

VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease.