New drug approvals - February 2024

 

 

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

Product NameEYBELIS-S OPHTHALMIC SOLUTION 0.002%W/V
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

 

Product NameSIDAPVIA FIXED DOSE COMBINATION TABLET 10 MG/100 MG
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

 

Product NameSOTYKTU FILM-COATED TABLETS 6 MG
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.

 

Product NameTECVAYLI SOLUTION FOR INJECTION 10MG/ML,
TECVAYLI SOLUTION FOR INJECTION 90MG/ML
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

 

Product NameVAXNEUVANCE® SUSPENSION FOR INJECTION
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.


 

 

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals