New drug approvals - August 2024

 

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

For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.

Product NameCOMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (SINGLE-DOSE VIAL)
Active Ingredient (Strength) Famtozinameran (5 μg/dose), Tozinameran (5 μg/dose)
Application type NDA-2: New presentation, strength
Product Registrant BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
Date of Approval 01/08/2024
Registration No. SIN17058P
Indications:
COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue 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 NameELZONRIS CONCENTRATE FOR SOLUTION FOR INFUSION 1000 MCG/ML
Active Ingredient (Strength) TAGRAXOFUSP (1.0 MG/mL)
Application type NDA-1: New biological entity
Product Registrant A. MENARINI SINGAPORE PTE. LTD.
Date of Approval 05/08/2024
Registration No. SIN17059P
Indications:
ELZONRIS is a CD123-directed cytotoxin indicated as monotherapy for first-line treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults.

Due to the rarity of the disease, the efficacy and safety of ELZONRIS as first-line treatment of BPDCN in adult patients has been demonstrated in a limited number of patients [see Clinical Studies (5.1.4)].

 

Product NameJYNNEOS SUSPENSION FOR INJECTION
Active Ingredient (Strength) Modified Vaccinia Ankara - Bavarian Nordic (MVA-BN, live, non-replicating) (0.5 x 10^8 to 3.95 x 10^8 Inf. U /dose)
Application type NDA-1: New biological entity
Product Registrant AENON PHARMACEUTICALS SEA PTE. LTD.
Date of Approval 23/08/2024
Registration No. SIN17067P
Indications:
JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or mpox infection.

 

Product NameSKIIP NICOTINE MINI LOZENGE 2 MG (CHERRY),
SKIIP NICOTINE MINI LOZENGE 4 MG (CHERRY),
SKIIP NICOTINE MINI LOZENGE 2 MG (CINNAMON),
SKIIP NICOTINE MINI LOZENGE 4 MG (CINNAMON)
Active Ingredient (Strength) Nicotine Polacrilex eqv to Nicotine(2.00 mg),
Nicotine Polacrilex eqv to Nicotine(4.00 mg),
Nicotine Polacrilex eqv to Nicotine(2.00 mg),
Nicotine Polacrilex eqv to Nicotine(4.00 mg)
Application type NDA-2/3: New flavours
Product Registrant RUBICON RESEARCH PRIVATE LIMITED
Date of Approval 14/08/2024
Registration No. SIN17060P,
SIN17061P,
SIN17062P,
SIN17063P
Indications:
The lozenge can alleviate some of the unpleasant withdrawal effects that frequently occur when giving up smoking, such as cravings and irritability. The lozenge can reduce your desire to smoke and help improve your willpower to resist smoking by providing some of the nicotine previously inhaled.

 

Product NameWINLEVI CREAM 1% W/W
Active Ingredient (Strength) Clascoterone (1% w/w)
Application type NDA-1: New chemical entity
Product Registrant HYPHENS PHARMA PTE. LTD.
Date of Approval 28/08/2024
Registration No. SIN17072P
Indications:
WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals