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.
June 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 |
| Vyzulta | Latanoprostene bunod | Drops (Eye/Ear) | 0.024% | Ophthalmic | Reduction of intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension | Bausch & Lomb | 01 Jun 2021 |
| Rybelsus | Semaglutide | Tablet | 3mg, 7mg, 14mg |
Oral | Treatment of adults with insufficiently controlled type 2 diabetes mellitus (adjunct to diet and exercise, when metformin is inappropriate or in combination with other products for diabetes) | Novo Nordisk Pharma | 01 Jun 2021 |
| Ibruvica | Ibrutinib | Tablet | 140mg, 280mg, 420mg, 560mg |
Oral | (i) Mantle Cell Lymphoma (MCL) (ii) Chronic lymphocytic leukemia / Small lymphocytic lymphoma (CLL/SLL) (iii) CLL/SLL with 17p deletion (iv) Waldenström’s macroglobulinemia (WM) |
Johnson & Johnson | 03 Jun 2021 |
| Mylotarg | Gemtuzumab ozogamicin | Vial | 5mg | Injection | (i) Newly-diagnosed acute myeloid leukemia (AML) (combination therapy) (ii) Patients with previously untreated, de novo CD33-positive AML, except acute promyelocytic leukemia (APL) (in combination with danorubicin and cytarabine) |
Pfizer | 21 Jun 2021 |
| Pelgraz | Pegfilgrastim | Pre-Filled Syringe/Pen | 6mg/0.6mL | Injection | Reduction in the duration of neutropenia and the incidence of febrile neutropenia (for patients on cytotoxic chemotherapy) | Accord Healthcare | 24 Jun 2021 |
| Phesgo | Pertuzumab / Trastuzumab | Vial | 1200mg / 600mg in 15mL, 600mg / 600mg in 10mL |
Injection | (i) Early breast cancer (EBC) (ii) Metastatic breast cancer (MBC) |
Roche | 22 Jun 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 |
| Fibryga | Human fibrinogen | Vial | 1g | Injection | Complementary therapy to management of uncontrolled severe haemorrhage in patients with acquired hypofibrinogenaemia in the course of surgical intervention | Wellchem Pharmaceuticals | 01 Jun 2021 |
| Dysport | Clostridium botulinum type a toxin-haemagglutinin complex | Vial | 300U, 500U |
Injection | Symptomatic treatment of focal spasticity of upper limbs in paediatric cerebral palsy patients (2 years of age or older) | Zuellig Pharma | 17 Jun 2021 |
| Menveo | Meningococcal vaccine | Vial | Not applicable | Injection | Active immunization of children (from 2 months of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y | GlaxoSmithKline | 30 Jun 2021 |
