New drug approvals - February 2024

Active Ingredient (Strength)

Omidenepag isopropyl(0.02 mg/mL)

Application type

NDA-2: New formulation

Product Registrant

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Date of Approval

19/02/2024

Registration No.

SIN16951P

Indications:
Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension

Active Ingredient (Strength)

Dapagliflozin propanediol monohydrate eqv Dapagliflozin(10mg), Sitagliptin phosphate monohydrate eqv Sitagliptin(100mg)

Application type

NDA-2: New dosage form

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

20/02/2024

Registration No.

SIN16958P

Indications:
SIDAPVIA is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and sitagliptin is appropriate.

*Evaluated via ACCESS

Active Ingredient (Strength)

Deucravacitinib(6.00 mg)

Application type

NDA-1: New chemical entity

Product Registrant

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

Date of Approval

04/02/2024

Registration No.

SIN16939P

Indications:
SOTYKTU is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Active Ingredient (Strength)

Teclistamab(10mg/mL),
Teclistamab(90mg/mL)

Application type

NDA-1: New biological entity
NDA-3: New strength

Product Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Date of Approval

16/02/2024

Registration No.

SIN16948P,
SIN16949P

Indications:
TECVAYLI® as monotherapy is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.

*Evaluated as part of Project Orbis

Active Ingredient (Strength)

(MBC) Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197(4μg),(MBC) Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197(2μg),(MBC) Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197(2μg)

Application type

NDA-1: New biological entity

Product Registrant

MSD PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

07/02/2024

Registration No.

SIN16944P

Indications:
VAXNEUVANCE is a vaccine indicated in infants, children and adolescents from 6 weeks through 17 years of age (prior to the 18th birthday) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.

VAXNEUVANCE is indicated in adults 18 years of age and older for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.

VAXNEUVANCE may not prevent disease caused by S. pneumoniae serotypes that are not contained in the vaccine.