New drug approvals - September 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 NameARCATUS® TRIAMCINOLONE ACETONIDE SUSPENSION FOR INJECTION 40 MG/ML
Active Ingredient (Strength) Triamcinolone acetonide(40MG/ML)
Application type NDA-2: New dosage form
Product Registrant ARCTIC VISION SINGAPORE PTE. LTD.
Date of Approval 19/09/2024
Registration No. SIN17090P
Indications:
ARCATUS® is indicated for the treatment of macular oedema associated with non-infectious uveitis.

 

Product NameAVAMAB CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/4ML,
AVAMAB CONCENTRATE FOR SOLUTION FOR INFUSION 400MG/16ML
Active Ingredient (Strength) Bevacizumab(100mg/4ml),
Bevacizumab(400mg/16ml)
Application type NDA-2: New biosimilar
Product Registrant INNOGENE KALBIOTECH PTE. LTD.
Date of Approval 25/09/2024
Registration No. SIN17101P,
SIN17102P

Indications:
Metastatic carcinoma of the colon or rectum(mCRC)
Avamab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.

Metastatic Breast Cancer (mBC)
Avamab in combination with paclitaxel is indicated for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer. Avamab in combination with capecitabine is indicated for first-line treatment of patients with HER2-negative metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12months should be excluded from treatment with Avamab in combination with capecitabine. The effective-ness of Avamab in metastatic breast cancer (mBC) is based on an improvement in progression-free survival.Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Avamab in breast cancer.

Non-Small Cell Lung Cancer (NSCLC)
Avamab, in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients withunresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer. Avamab,in combination with erlotinib, is indicated for first-line treatment of patients with unresectable advanced,metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor(EGFR) activating mutations.

Malignant Glioma (WHO Grade IV) – Glioblastoma
Avamab, as a single agent is indicated for the treatment of patients with glioblastoma after relapse ordisease progression following prior therapy. The effectiveness of Avamab in glioblastoma is based on animprovement in objective response rate. There are no data demonstrating an improvement in disease-relat-ed symptoms or increased survival with Avamab.

Advanced and/or metastatic renal Cell Cancer (mRCC)
Avamab in combination with interferon alfa-2a is indicated for first-line treatment of patients with advanced and/or metastatic renal cell cancer.

Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer
Avamab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of advanced(FIGO stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Avamab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel is indicatedfor the treatment of patients with recurrent, platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors. Avamab in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents.

Cervical Cancer
Avamab in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix.

 

Product NameENOXAPARIN SANDOZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 8,000 IU (80 MG)/ 0.8 ML,
ENOXAPARIN SANDOZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6,000 IU (60 MG)/ 0.6 ML,
ENOXAPARIN SANDOZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 4,000 IU (40 MG)/ 0.4 ML,
ENOXAPARIN SANDOZ SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 2,000 IU (20 MG)/ 0.2 ML
Active Ingredient (Strength) Enoxaparin Sodium(8,000 IU (80 MG) /0.8 ML),
Enoxaparin Sodium(6,000 IU (60 MG) /0.6 ML),
Enoxaparin Sodium(4,000 IU (40 MG) /0.4 ML),
Enoxaparin Sodium(2,000 IU (20 MG) /0.2 ML)
Application type NDA-2/3: New biosimilar
Product Registrant SANDOZ SINGAPORE PTE. LTD.
Date of Approval 11/09/2024
Registration No. SIN17084P,
SIN17086P,
SIN17085P,
SIN17083P
Indications:
Prophylaxis of venous thromboembolic disease (prevention of blood clot formation in the veins), in particular those which may be associated with orthopedic or general surgery.
Prophylaxis of venous thromboembolic disease in medical patients bedridden due to acute illnesses.
Treatment of established deep vein thrombosis.
Prevention of thrombus formation in extracorporeal circulation during haemodialysis.
Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.
Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), in combination with a thrombolytic agent, in patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI)

 

Product NameFOSTER NEXTHALER INHALATION POWDER 200 MCG/6 MCG PER DOSE,
FOSTER PRESSURISED INHALATION SOLUTION 200MCG/6MCG PER ACTUATION
Active Ingredient (Strength) Beclometasone dipropionate(0.200mg/dose),Formoterol fumarate dihydrate(0.006mg/dose),
Beclometasone dipropionate(0.200mg/actuation),Formoterol fumarate dihydrate(0.006mg/actuation)
Application type NDA-2: New presentation
Product Registrant ORIENT EUROPHARMA PTE LTD
Date of Approval 25/09/2024
Registration No. SIN17099P,
SIN17100P
Indications:
Foster Nexthaler is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-actingbeta2-agonist or
- patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.
Foster Nexthaler is indicated in adults.
Note: there are no relevant clinical data on the use of Foster Nexthaler for the treatment of acute asthma attacks.

 

Product NameILUMYA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/ML
Active Ingredient (Strength) Tildrakizumab(100mg/mL)
Application type NDA-1: New biological entity
Product Registrant RANBAXY (MALAYSIA) SDN. BHD.
Date of Approval 04/09/2024
Registration No. SIN17076P
Indications:
Tildrakizumab is an interleukin-23 antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

 

Product NameORSERDU FILM-COATED TABLET 345 MG,
ORSERDU FILM-COATED TABLET 86 MG
Active Ingredient (Strength) ELACESTRANT DIHYDROCHLORIDE eqv ELACESTRANT(345 MG),
ELACESTRANT DIHYDROCHLORIDE eqv ELACESTRANT(86 MG)
Application type NDA-1/3: New chemical entity
Product Registrant A. MENARINI SINGAPORE PTE. LTD.
Date of Approval 25/09/2024
Registration No. SIN17096P,
SIN17097P
Indications:
ORSERDU monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.

 

Product NameSTELARA SOLUTION FOR INJECTION IN PRE-FILLED PEN 90MG/1ML
Active Ingredient (Strength) Ustekinumab(90mg/1ml)
Application type NDA-2: New presentation
Product Registrant JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Date of Approval 26/09/2024
Registration No. SIN17103P

Indications:
Plaque Psoriasis:
STELARA®is indicated for the treatment of adult patients (18 years or older) with moderate tosevere plaque psoriasis who failed to respond to, or who have a contraindication to, or areintolerant to other systemic therapies including cyclosporin, methotrexate or PUVA.
Pediatric Plaque Psoriasis:
STELARA®is indicated for the treatment of pediatric patients (children and adolescents) (6years and older) with moderate to severe plaque psoriasis who are inadequately controlled by, orare intolerant to, other systemic therapies or phototherapies.
Psoriatic Arthritis (PsA):
STELARA®, alone or in combination with methotrexate (MTX), is indicated for:
∙the treatment of adult patients (18 years or older) with active psoriatic arthritis when theresponse to previous non-biological disease-modifying anti-rheumatic drug (DMARD)therapy has been inadequate
∙inhibiting the progression of structural damage
Crohn’s Disease:
STELARA 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
Ulcerative Colitis:
STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies

 

 

Product NameTEPADINA POWDER AND SOLVENT FOR SOLUTION FOR INFUSION 400MG
Active Ingredient (Strength) Thiotepa(400mg)
Application type NDA-2: New presentation
Product Registrant AXXESSBIO PTE. LTD.
Date of Approval 20/09/2024
Registration No. SIN17095P

Indications:

TEPADINA is indicated, in combination with other chemotherapy medicinal products:

  • with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;
  • when high dose chemotherapy with HPCT support is appropriate for the treatment of breast cancer in adult patients and CNS tumours in paediatric patients.

 

Product NameTEVIMBRA CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/10ML
Active Ingredient (Strength) Tislelizumab(100mg/10mL )
Application type NDA-1: New biological entity
Product Registrant BEIGENE SINGAPORE PTE. LTD.
Date of Approval 19/09/2024
Registration No. SIN17089P
Indications:
Non-small cell lung cancer (NSCLC)

TEVIMBRA in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have:
∙ locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or
∙ metastatic NSCLC.

TEVIMBRA in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous NSCLC who have:
∙ locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or
∙ metastatic NSCLC.

TEVIMBRA as monotherapy is indicated for the treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy.

Esophageal squamous cell carcinoma (ESCC)

TEVIMBRA as monotherapy is indicated for the treatment of patients with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) after prior chemotherapy.

 

Product NameWINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG,
WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 60MG,
WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG (VIAL ONLY),
WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 60MG (VIAL ONLY)
Active Ingredient (Strength) (Powder vial) sotatercept(45mg),
(Powder vial) sotatercept(60mg),
Sotatercept(45mg),
Sotatercept(60mg)
Application type NDA-1/3: New biological entity
Product Registrant MSD PHARMA (SINGAPORE) PTE. LTD.
Date of Approval 20/09/2024
Registration No. SIN17091P,
SIN17092P,
SIN17093P,
SIN17094P

Indications:
WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1; Functional Class [FC] II to III) to increase exercise capacity, improve WHO functional class, and delay disease progression

*Evaluated via Access

 

Product NameZYNLONTA® FOR INJECTION 10MG/VIAL
Active Ingredient (Strength) Loncastuximab tesirine(10mg/vial)
Application type NDA-1: New biological entity
Product Registrant ORIENT EUROPHARMA PTE LTD
Date of Approval 25/09/2024
Registration No. SIN17098P
Indications:
ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This indication is approved based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

 

 

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals