New drug approvals - August 2025

Active Ingredient (Strength)

Adalimumab(40mg/0.4mL),
Adalimumab(20mg/0.2mL)

Application type

NDA-2: Biosimilar

Product Registrant

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Date of Approval

13/08/2025

Registration No.

SIN17306P,
SIN17307P

Indications:
ADULTS
Rheumatoid Arthritis
AMGEVITA is indicated for reducing signs and symptoms and inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs. AMGEVITA can be used alone or in combination with methotrexate or other DMARDs.
AMGEVITA, in combination with MTX, can also be used in the treatment of patients with recently diagnosed moderate to severely active rheumatoid arthritis who have not received methotrexate.
Psoriatic Arthritis
AMGEVITA is indicated for reducing signs and symptoms of active arthritis in adult patients with moderate to severe psoriatic arthritis when the response to previous DMARD therapy has been inadequate. AMGEVITA has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. AMGEVITA can be used alone or in combination with DMARDs.
Ankylosing Spondylitis
AMGEVITA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Crohn’s Disease
AMGEVITA is indicated for the treatment of moderate to severe active Crohn’s disease in adults to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients who have had an inadequate response to conventional therapies, or who have lost response to or are intolerant of infliximab. For induction treatment, AMGEVITA should be given in combination with corticosteroids. AMGEVITA can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inadequate.
Ulcerative Colitis
AMGEVITA is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Plaque Psoriasis
AMGEVITA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate.
Hidradenitis Suppurativa
AMGEVITA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.
Uveitis
AMGEVITA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
 
PEDIATRICS
Juvenile Idiopathic Arthritis
Polyarticular Juvenile Idiopathic Arthritis
AMGEVITA in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA), in patients 2 years of age and older, who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDS). AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see CLINICAL STUDIES). AMGEVITA has not been studied in patients aged less than 2 years.
Enthesitis-Related Arthritis
AMGEVITA is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.
Pediatric Crohn's Disease
AMGEVITA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients, 6 years of age and older, with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.
Pediatric Plaque Psoriasis
AMGEVITA is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.
Adolescent Hidradenitis Suppurativa
AMGEVITA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic hidradenitis suppurativa (HS) therapy.
Pediatric Uveitis
AMGEVITA is indicated for the treatment of chronic non-infectious anterior uveitis in pediatric patients 2 years of age and older who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Pediatric Ulcerative Colitis
AMGEVITA is indicated for inducing and maintaining clinical remission in pediatric patients 5 years of age or older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or 6- mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

Active Ingredient (Strength)

Remimazolam besylate eqv Remimazolam(20 mg)

Application type

NDA-1

Product Registrant

HYPHENS PHARMA PTE. LTD.

Date of Approval

27/08/2025

Registration No.

SIN17317P

Indications:
1. The induction and maintenance of general anesthesia in adults
2. The induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less

Active Ingredient (Strength)

Iptacopan hydrochloride monohydrate eqv Iptacopan(200.0mg)

Application type

NDA-1

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

06/08/2025

Registration No.

SIN17304P

Indications:
Fabhalta is indicated as monotherapy for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have haemolytic anaemia.

Active Ingredient (Strength)

FINASTERIDE(2.275 mg/mL)

Application type

NDA-2

Product Registrant

A. MENARINI SINGAPORE PTE. LTD.

Date of Approval

05/08/2025

Registration No.

SIN17303P

Indications:
Topical treatment of adult men from 18 to 41 years of age with mild to moderate male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss.

Active Ingredient (Strength)

Tarlatamab(1 mg/vial ),
Tarlatamab(10 mg/vial)

Application type

NDA-1,
NDA-3

Product Registrant

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Date of Approval

01/08/2025

Registration No.

SIN17299P,
SIN17300P

Indications:
IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

*Evaluated via Project Orbis

Active Ingredient (Strength)

Futibatinib(4.0 mg)

Application type

NDA-1

Product Registrant

TAIHO PHARMA ASIA PACIFIC PTE. LTD.

Date of Approval

25/08/2025

Registration No.

SIN17316P

Indications:
LYTGOBI monotherapy 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 have progressed after at least one prior line of systemic therapy.

Active Ingredient (Strength)

Ustekinumab(45 mg/0.5ml),
Ustekinumab(90 mg/ml),
Ustekinumab(130 mg/26ml)

Application type

NDA-2,
NDA-3,
NDA-2: Biosimilar

Product Registrant

CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

Date of Approval

14/08/2025

Registration No.

SIN17308P,
SIN17309P,
SIN17310P

Indications:
Plaque Psoriasis:
STEQEYMA® is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate or PUVA.
Pediatric Plaque Psoriasis:
STEQEYMA® is indicated for the treatment of pediatric patients (children and adolescents) (6 years and older) with moderate to severe plaque psoriasis who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Psoriatic Arthritis (PsA):
STEQEYMA®, alone or in combination with methotrexate (MTX), is indicated for:
• the treatment of adult patients (18 years or older) with active psoriatic arthritis when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate
• inhibiting the progression of structural damage
Crohn’s Disease:
STEQEYMA® is indicated for the treatment of adults with moderately to severe active Crohn’s disease who have:
failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker or failed or were intolerant to treatment with one or more TNF blockers

Active Ingredient (Strength)

Eplontersen sodium eqv Eplontersen(45mg/0.8ml)

Application type

NDA-1

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

15/08/2025

Registration No.

SIN17311P

Indications:
WAINUA is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with Stage 1 or 2 polyneuropathy.