Listing of approvals 

View the lists of therapeutic products approvals and new indications approved for registered therapeutic products. 

For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.

New Drug Applications (NDA)

  • Please click here for a list of summary reports of benefit-risk assessments.
  • Please click here for description of application types.


 

Approval Date Product Name Active Ingredient(s) Application Type Product Registrant Licence Number
15-01-2026 EMBLAVEO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1.5G/0.5G

* Evaluated via ASEAN Joint review		 Avibactam Sodium eqv Avibactam(0.5 g/vial ),Aztreonam(1.5 g/vial) NDA-2 PFIZER PRIVATE LIMITED SIN17438P
15-01-2026 JUBBONTI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 60MG/ML Denosumab(60 mg/ml) NDA-2: Biosimilar SANDOZ SINGAPORE PTE. LTD. SIN17439P
15-01-2026 WYOST SOLUTION FOR INJECTION 120MG/1.7ML Denosumab(120 mg/1.7ml) NDA-2: Biosimilar SANDOZ SINGAPORE PTE. LTD. SIN17440P
14-01-2026 VALTOCO NASAL SPRAY 10MG/SPRAY Diazepam(10mg/spray) NDA-2 RXILIENT MEDICAL PTE LTD SIN17435P
14-01-2026 VALTOCO NASAL SPRAY 5MG/SPRAY Diazepam(5.00mg/spray) NDA-3 RXILIENT MEDICAL PTE LTD SIN17437P
14-01-2026 VALTOCO NASAL SPRAY 7.5MG/SPRAY Diazepam(7.5mg/ spray) NDA-3 RXILIENT MEDICAL PTE LTD SIN17436P
13-01-2026 FRAGMIN SOLUTION FOR INJECTION PREFILLED SYRINGE 2500 IU/0.2 ML Dalteparin Sodium(2500 IU/0.2ml) NDA-2 PFIZER PRIVATE LIMITED SIN17433P
13-01-2026 FRAGMIN SOLUTION FOR INJECTION PREFILLED SYRINGE 5000 IU/0.2 ML Dalteparin Sodium(5000 IU/0.2ml) NDA-3 PFIZER PRIVATE LIMITED SIN17434P
07-01-2026 PAXLOVID (NIRMATRELVIR AND RITONAVIR) FILM-COATED TABLETS Nirmatrelvir(150 mg),Ritonavir(100 mg) NDA-2 PFIZER PRIVATE LIMITED SIN17428P

Click here to view older listings of new drug approvals

Generic Drug Applications (GDA)

 


Approval date Product Name   Active ingredient (s) Application Type  Product Registrant Licence number
29-01-2026 PHENASEN CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/10ML Arsenic Trioxide(10mg/10ml) GDA-1 PHEBRA (SE ASIA) PTE. LTD. SIN17447P
27-01-2026 MOXICLAV POWDER FOR SOLUTION FOR INJECTION/ INFUSION 1.2G/VIAL Amoxicillin sodium eqv. to Amoxicillin(1000mg/vial),Potassium clavulanate eqv. to Clavulanic acid(200mg/vial) GDA-1 MEDOCHEMIE SINGAPORE PTE. LTD. SIN17446P
23-01-2026 JAMP-CHOLESTYRAMINE POWDER FOR ORAL SUSPENSION 4G Cholestyramine resin(4000mg) GDA-1 GOLDPLUS UNIVERSAL PTE LTD SIN17445P
22-01-2026 ZYGABALIN HARD CAPSULE 150MG Pregabalin(150mg) GDA-1 APEX PHARMA MARKETING PTE. LTD. SIN17442P
22-01-2026 ZYGABALIN HARD CAPSULE 75MG Pregabalin(75mg) GDA-2 APEX PHARMA MARKETING PTE. LTD. SIN17443P
22-01-2026 ZYGABALIN HARD CAPSULE 50MG Pregabalin(50mg) GDA-2 APEX PHARMA MARKETING PTE. LTD. SIN17444P
16-01-2026 GP-KETOPROFEN PLASTER 30MG/PLASTER Ketoprofen(30 mg/plaster) GDA-1 GOLDPLUS UNIVERSAL PTE LTD SIN17441P
13-01-2026 EBUNAT SOLUTION FOR INJECTION 0.5MG/ML ERIBULIN MESYLATE(0.5 mg/ml) GDA-1 NATCO PHARMA ASIA PTE. LTD. SIN17432P
09-01-2026 APIGAT 5 FILM COATED TABLETS 5 MG Apixaban(5.00mg) GDA-1 NATCO PHARMA ASIA PTE. LTD. SIN17430P
09-01-2026 MICAFUNGIN-AFT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 50MG/VIAL MICAFUNGIN SODIUM EQUIVALENT TO MICAFUNGIN(50MG/vial) GDA-1 APEX PHARMA MARKETING PTE. LTD. SIN17429P
09-01-2026 APIGAT 2.5 FILM COATED TABLETS 2.5MG Apixaban(2.5mg) GDA-2 NATCO PHARMA ASIA PTE. LTD. SIN17431P
06-01-2026 DAPIGA FILM COATED TABLETS 10MG Dapagliflozin(10 mg) GDA-1 SEA PHARMA CONSULTANCY PTE LTD SIN17427P

Click here to view older listings of new drug approvals.

Major Variation Applications (MAV)


Approval DateProduct NameActive Ingredient(s)Product RegistrantLicence NumberIndication
29-01-2026GAMUNEX®-C SOLUTION FOR INFUSION 10%Human Normal Immunoglobulin(0.1g /mL)GRIFOLS ASIA PACIFIC PTE. LTD.SIN14928PReplacement therapy in adults, children and adolescents (0-18 years) in:
• Primary immunodeficiency syndromes (PID) with impaired antibody production
• Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l
*PSAF = failure to mount at least a 2-fold rise in IgG antibody titer to pneumococcal polysaccharide and polypeptide antigen vaccines

Measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (0-18 years) in whom active immunization is contraindicated or not advised.
Consideration should also be given to official recommendations on intravenous human

Immunomodulation in adults aged ≥18 years in:
• Severe acute exacerbations of myasthenia gravis
Immunomodulation in adults aged ≥18 years in:
• Severe acute exacerbations of myasthenia gravis
immunoglobulin use in measles pre-/post exposure prophylaxis and active immunization.

Immunomodulation in adults, children and adolescents (0-18 years) in:
• Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count
• Guillain Barré syndrome
• Kawasaki disease (in conjunction with acetylsalicylic acid; see 4.2)
• Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
• Multifocal motor neuropathy (MMN)
15-01-2026ZAVICEFTA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 2G/0.5GAvibactam sodium 543.5 mg eqv. to Avibactam(500mg),Ceftazidime pentahydrate 2329.7 mg eqv. to Ceftazidime(2g)PFIZER PRIVATE LIMITEDSIN15870PZavicefta is indicated in adults and paediatric patients from birth for the treatment of the
following infections (see sections 4.4 and 5.1):
- Complicated Intra-Abdominal Infection (cIAI)
- Complicated Urinary Tract Infection (cUTI), including pyelonephritis
- Hospital-acquired Pneumonia (HAP), including ventilator associated pneumonia (VAP)

Click here to view older listings of drug indication approvals.

Reclassifications

View the list of reclassified therapeutic products (MAV-2).