New drug approvals - July 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 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. |
| 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. |
| 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). |
| 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). |
| 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 |
| 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). |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Approvals