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Health Sciences Authority
New Drug Approvals

New drug approvals - July 2024

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

12 September 2024

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

  • 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.

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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.

Table caption

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).

Table caption

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).

Table caption

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

Table caption

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).


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