New Drug Approvals

New drug approvals - August 2024

11 October 2024

Audiences

Healthcare professional

Industry member

Product-type

Therapeutic Products

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Please click here (opens in new tab) 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.

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Product Name	COMIRNATY 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.

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Product Name	ELZONRIS 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)].

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Product Name	JYNNEOS 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.

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Product Name	SKIIP 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.

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Product Name	WINLEVI 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.