New drug approvals - December 2023

Product Name

COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (MDV)

Active Ingredient

Famtozinameran(5 μg/dose),Tozinameran(5 μg/dose)

Application type

NDA-2: New combination

Product Registrant

BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.

Date of Approval

18/12/2023

Registration No.

SIN16915P

Indications:

COMIRNATY (Bivalent) (For Age 5 Years to < 12 Years) (Vials with Orange Cap) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 5 to < 12 years of age. The use of this vaccine should be in accordance with official recommendations.

Product Name

LIPOCOMB HARD CAPSULE 20MG/10MG,
LIPOCOMB HARD CAPSULE 10MG/10MG

Active Ingredient

EZETIMIBE (10.00mg), ROSUVASTATIN ZINC EQV ROSUVASTATIN (20.00mg),
EZETIMIBE (10.00mg), ROSUVASTATIN ZINC EQV ROSUVASTATIN (10.00mg)

Application type

NDA-2: New combination

Product Registrant

SERVIER (S) PTE LTD

Date of Approval

21/12/2023

Registration No.

SIN16919P, SIN16920P

Indications:

Lipocomb is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products.

Product Name

NGENLA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 24 MG/1.2ML,
NGENLA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 60 MG/1.2ML

Active Ingredient

Somatrogon(24mg/1.2ml),
Somatrogon(60mg/1.2ml)

Application type

NDA-1: New biological entity

NDA-3: Subsequent strength

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

14/12/2023

Registration No.

SIN16911P, SIN16912P

Indications:

NGENLA is indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone (GH).

Product Name

PLUVICTO SOLUTION FOR INJECTION/INFUSION 1000 MBQ/ML

Active Ingredient

Lutetium (177 Lu) vipivotide tetraxetan (1000 MBq/mL)

Application type

NDA-1: New chemical entity

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

18/12/2023

Registration No.

SIN16917P

Indications:

Pluvicto® is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibitor and taxane-based chemotherapy.

*Evaluated as part of Project Orbis

Product Name

TRECONDI POWDER FOR SOLUTION FOR INFUSION 5 G PER VIAL,
TRECONDI POWDER FOR SOLUTION FOR INFUSION 1 G PER VIAL

Active Ingredient

Treosulfan (5 g / vial),
Treosulfan (1 g / vial)

Application type

NDA-1: New chemical entity

NDA-3: Subsequent strength

Product Registrant

LINK HEALTHCARE SINGAPORE PTE LTD

Date of Approval

26/12/2023

Registration No.

SIN16922P, SIN16923P

Indications:

Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) at increased risk of toxicity with standard conditioning therapies, and in paediatric patients older than one month with malignant diseases.

Product Name

TRELEGY ELLIPTA INHALATION POWDER 200 MCG/62.5 MCG/25 MCG

Active Ingredient

FLUTICASONE FUROATE (MICRONISED)(200 MCG),UMECLIDINIUM BROMIDE (MICRONISED) EQV TO UMECLIDINIUM(62.5 MCG),VILANTEROL TRIFENATATE (MICRONISED) EQV TO VILANTEROL(25 MCG)

Application type

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

15/12/2023

Registration No.

SIN16914P

Indications:

ASTHMA

Trelegy Ellipta is indicated for the maintenance treatment of asthma in patients aged 18 years and older who are not adequately controlled with a combination of a long-acting beta2-agonist and an inhaled corticosteroid.

COPD

Trelegy Ellipta is indicated for maintenance treatment to prevent and relieve symptoms associated with moderate to severe chronic obstructive pulmonary disease (COPD) in patients who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (see Clinical Studies).