New Drug Approvals

New drug approvals - July 2024

12 September 2024

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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	ABRYSVO POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Active Ingredient (Strength)	(Powder) RSV subgroup A stabilized prefusion F protein(0.06 mg/vial),(Powder) RSV subgroup B stabilized prefusion F protein(0.06 mg/vial)
Application type	NDA-1: New biological entity
Product Registrant	PFIZER PRIVATE LIMITED
Date of Approval	23/07/2024
Registration No.	SIN17049P
Indications: 1.1 Immunization of Pregnant Individuals ABRYSVO is a vaccine indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. 1.2 Immunization of Individuals 60 Years of Age and Older ABRYSVO is a vaccine indicated for active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older.

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Product Name	COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 1.5/1.5 MICROGRAMS/DOSE
Active Ingredient (Strength)	Famtozinameran(1.5 μg/dose),Tozinameran(1.5 μg/dose)
Application type	NDA-2: New dosage form, strength, combination
Product Registrant	BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
Date of Approval	25/07/2024
Registration No.	SIN17053P
Indications: COMIRNATY (Bivalent) (For Age 6 Months to < 5 years) (Vials with Maroon Cap) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 6 months to < 5 years of age. The use of this vaccine should be in accordance with official recommendations.

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Product Name	EYLEA SOLUTION FOR INJECTION 114.3 MG/ML
Active Ingredient (Strength)	Aflibercept(114.3mg/ml)
Application type	NDA-2: New strength, dosing regimen
Product Registrant	BAYER (SOUTH EAST ASIA) PTE LTD
Date of Approval	05/07/2024
Registration No.	SIN17040P
Indications: Eylea is indicated in adults for the treatment of - neovascular (wet) age-related macular degeneration (nAMD) (see section 5.1) - visual impairment due to diabetic macular oedema (DME) (see section 5.1).

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Product Name	LITFULO CAPSULE 50MG
Active Ingredient (Strength)	Ritlecitinib Tosylate equivalent to Ritlecitinib(50mg)
Application type	NDA-1: New chemical entity
Product Registrant	PFIZER PRIVATE LIMITED
Date of Approval	05/07/2024
Registration No.	SIN17041P
Indications: LITFULO is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older (see section 5.1).

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Product Name	MEGAPTH-G SOLUTION FOR INJECTION 20 MCG/80MCL CARTRIDGE PACK, MEGAPTH-G SOLUTION FOR INJECTION 20 MCG/80MCL PEN + CARTRIDGE PACK
Active Ingredient (Strength)	Teriparatide(20 mcg/80 mcl)
Application type	NDA-2: biosimilar
Product Registrant	GOLDPLUS UNIVERSAL PTE LTD
Date of Approval	24/07/2024
Registration No.	SIN17051P, SIN17052P
Indications: Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Teriparatide is indicated for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture. These include women with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant of previous osteoporosis therapy, based upon physician assessment. In postmenopausal women with osteoporosis, teriparatide increases BMD and reduces the risk of vertebral and nonvertebral fractures. Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture Teriparatide is indicated to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. These include men with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment. In men with primary or hypogonadal osteoporosis, Teriparatide increases BMD. The effects of Teriparatide on risk for fracture in men have not been studied. Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture

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Product Name	PEMAZYRE TABLETS 13.5 MG, PEMAZYRE TABLETS 9 MG, PEMAZYRE TABLETS 4.5 MG
Active Ingredient (Strength)	Pemigatinib(13.50 mg), Pemigatinib(9.00 mg), Pemigatinib(4.50 mg)
Application type	NDA-1: New chemical entity NDA-3: New strength
Product Registrant	SPECIALISED THERAPEUTICS ASIA PTE LTD
Date of Approval	09/07/2024
Registration No.	SIN17044P, SIN17043P, SIN17042P
Indications: Pemigatinib is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR).