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.
May 2021
- New drugs approved: 6
- 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 |
| Replagal | Agalsidase alfa | Vial | 1mg/mL | Injection | Long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease | Takeda Pharmaceuticals | 17 May 2021 |
| Crysvita | Burosumab | Vial | 10mg/mL, 20mg/mL, 30mg/mL |
Injection | Treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older. | Kyowa Kirin | 03 May 2021 |
| Aprovasc | Irbesartan/ Amlodipine besilate | Tablet | 150mg / 5mg, 300mg / 5mg, 300mg / 10mg |
Oral | Treatment of hypertension in adult patients in whom blood pressure is not adequately controlled on irbesartan or amlodipine monotherapy | Sanofi-Aventis | 14 May 2021 |
| Evenity | Romosozumab | Pre-Filled Syringe/Pen | 105mg/1.17mL | Injection | Treatment of severe osteoporosis in postmenopausal women at high risk of fracture. | Amgen Biotechnology | 27 May 2021 |
| Kanjinti | Trastuzumab | Vial | 150mg, 440mg |
Injection | Metastatic breast cancer (MBC) / Early breast cancer (EBC) / Metastatic gastric cancer (MGC) | Amgen Biotechnology | 25 May 2021 |
| Remleas | Valbenazine | Capsule | 40mg | Oral | Treatment of adults with tardive dyskinesia | Mitsubishi Tanabe Pharma | 19 May 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 |
| Soliqua | Insulin glargine/ Lixisenatide | Pre-Filled Syringe/Pen | 100units/mL / 50mcg/mL, 100units/mL / 33mcg/mL |
Injection | Treatment of adults with insufficiently controlled type 2 diabetes mellitus (adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors) | Sanofi-Aventis | 07 May 2021 |
| Diphereline | Triptorelin pamoate | Vial | 11.25mg | Injection | High-risk localised or locally advanced prostate cancer – adjuvant treatment to radiotherapy | Zuellig Pharma | 10 May 2021 |
| Opdivo | Nivolumab | Vial | 10mg/mL | Injection | Oesophageal Squamous Cell Carcinoma (OSCC) – treatment of adult patients with unresectable advanced, recurrent or metastatic OSCC after prior fluoropyrimidine- and platinum-based combination chemotherapy | Bristol-Myers Squibb | 12 May 2021 |
