Health Sciences Authority (HSA) is Singapore’s national authority regulating health products, including medications. Every month, HSA publishes a list of medications that are newly approved or medications with newly approved indication(s). This list can be found on HSA’s website.
April 2021
- New drugs approved: 8
- New drug indications approved: 3
New drugs approved
Product name | Active ingredient(s) | Dosage Form | Strength of dosage form | Route of Administration | Indication(s) | Pharmaceutical company | Approval Date |
Mvasi | Bevacizumab | Vial | 25mg/mL | Injection | Metastatic carcinoma of the colon or rectum (mCRC)
Metastatic breast cancer (mBC) Non-Small Cell Lung Cancer (NSCLC) Malignant Glioma (WHO Grade IV) – Glioblastoma Advanced and/or metastatic Renal Cell Cancer (mRCC) Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer Cervical Cancer |
Amgen Biotechnology | 10 Apr 2021 |
Crysvita | Burosumab | Vial | 10mg/mL
20mg/mL 30mg/mL |
Injection | Treatment of X-linked hypophosphatemia | Kyowa Kirin | 30 Apr 2021 |
Veraseal | Human Fibrinogen/ Human Thrombin | Solution (Topical) | 80 IU/mL/ 500 mg/mL | Topical | Improvement of haemostasis
Suture support: in vascular surgery |
Grifols | 01 Apr 2021 |
Enerzair Breezhaler | Indacaterol/ Glycopyrronium/ Mometasone furoate | Inhaler | 150mcg/ 50mcg/ 160mcg | Inhalation | Maintenance treatment of asthma
Reduce asthma exacerbations |
Novartis | 14 Apr 2021 |
Atectura Breezhaler | Indacaterol/ Mometasone furoate | Inhaler | 150mcg/ 80mcg
150mcg/ 160mcg 150mcg/ 320mcg |
Inhalation | Maintenance treatment of asthma | Novartis | 07 Apr 2021 |
Nucala | Mepolizumab | Pre-Filled Syringe/Pen | 100mg/mL | Injection | Severe eosinophilic asthma
Eosinophilic Granulomatosis with Polyangiitis (EGPA) |
GlaxoSmithKline | 27 Apr 2021 |
Eybelis | Omidenepag Isopropyl | Drops (Eye/Ear) | 0.002% | Ophthalmic | Open-angle glaucoma or ocular hypertension – reduction of elevated intraocular pressure | Santen Pharmaceutical | 07 Apr 2021 |
Ozempic | Semaglutide | Pre-Filled Syringe/Pen | 0.25mg
0.5mg 1mg |
Injection | Insufficiently controlled type 2 diabetes mellitus | Novo Nordisk Pharma | 21 Apr 2021 |
New drug indications approved
Product name | Active ingredient(s) | Dosage Form | Strength of dosage form | Route of Administration | Indication (s) | Pharmaceutical company | Approval Date |
Lynparza | Olaparib | Tablet | 100mg
150mg |
Oral | Advanced (FIGO stages III and IV) high grade epithelial ovarian, fallopian tube or primary peritoneal cancer | AstraZeneca | 28 Apr 2021 |
Ibrance | Palbociclib | Capsule | 75mg
100mg 125mg |
Oral | Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer | Pfizer | 06 Apr 2021 |
Stelara | Ustekinumab | Pre-Filled Syringe/Pen | 45mg/0.5mL
90mg/1mL |
Injection | Paediatric patients (6 years and older) with moderate to severe plaque psoriasis | Johnson & Johnson | 27 Apr 2021 |