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.
October 2021
- New drugs approved: 10
- New drug indications approved: 10
New drugs approved
| Product name | Active ingredient(s) | Dosage Form | Strength of dosage form | Route of Administration | Indication(s) | Pharmaceutical company | Approval Date |
| Tabrecta | Capmatinib | Tablet | 150mg, 200mg | Oral | Adult patients with metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation. | Novartis | 22 Oct 2021 |
| Ajovy | Fremanezumab | Pre-Filled Syringe/Pen | 225mg/1.5mL | Injection | Preventive treatment of migraine in adults. | Teva Pharmaceutical | 04 Oct 2021 |
| Latuda | Lurasidone | Tablet | 20mg | Oral | (i) Adult and adolescent patients age 13 to 17 years with schizophrenia (ii) Adult and paediatric patients (13 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) (iii) Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) |
DKSH | 12 Oct 2021 |
| Polivy | Polatuzumab vedotin | Vial | 30mg | Injection | Treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma who are not eligible for haematopoietic cell transplant (in combination with bendamustine and MabThera) | Roche | 05 Oct 2021 |
| Skyrizi | Risankizumab | Pre-Filled Syringe/Pen | 150mg/mL | Injection | Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy | Abbvie | 01 Oct 2021 |
| Evrysdi | Risdiplam | Powder | 0.75mg/mL | Oral | Spinal muscular atrophy (SMA) in patients 2 months of age and older | Roche | 20 Oct 2021 |
| Enspryng | Satralizumab | Pre-Filled Syringe/Pen | 120mg/1mL | Injection | Treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescents who are anti-aquaporin 4 (AQP4) seropositive. | Roche | 19 Oct 2021 |
| Enhertu | Trastuzumab deruxtecan | Vial | 100mg | Injection | (i) Unresectable or metastatic HER2-positive breast cancer (ii) Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma |
AstraZeneca | 22 Oct 2021 |
| Verquvo | Vericiguat | Tablet | 2.5mg, 5mg, 10mg | Oral | Symptomatic chronic heart failure in adult patients with reduced ejection fraction, who are stabilised after a recent decompensation event requiring IV therapy | Bayer | 01 Oct 2021 |
| Brukinsa | Zanubrutinib | Capsule | 80mg | Oral | Adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. | Beigene Singapore | 01 Oct 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 |
| Xofluza | Baloxavir marboxil | Tablet | 20mg, 40mg | Oral | (i) Treatment of influenza (ii) Prophylaxis of influenza |
Roche | 19 Oct 2021 |
| Kyprolis | Carfilzomib | Vial | 30mg, 60mg | Injection | Adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with daratumumab and dexamethasone. | Amgen Biotechnology | 20 Oct 2021 |
| Forxiga | Dapagliflozin | Tablet | 5mg, 10mg | Oral | Adjunct to standard therapy to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular (CV) death in adults with chronic kidney disease at risk of progression | AstraZeneca | 29 Oct 2021 |
| Darzalex | Daratumumab | Vial | 100mg/5mL, 400mg/20mL |
Injection | Multiple myeloma, in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. | Johnson & Johnson | 20 Oct 2021 |
| Jardiance | Empagliflozin | Tablet | 10mg | Oral | Adult patients with heart failure (NYHA class II-IV) and reduced ejection fraction, with or without type 2 diabetes mellitus to reduce the risk of cardiovascular death and hospitalization for heart failure | Boehringer Ingelheim | 28 Oct 2021 |
| Fiasp | Insulin Aspart | Vial | 100units/mL | Injection | Diabetes mellitus in adults, adolescents and children aged 2 years and above | Novo Nordisk Pharma | 01 Oct 2021 |
| Taltz | Ixekizumab | Pre-Filled Syringe/Pen | 80mg/mL | Injection | Treatment of moderate to severe plaque psoriasis in children from the age of 6 years | DKSH | 28 Oct 2021 |
| Latuda | Lurasidone | Tablet | 40mg, 80mg | Oral | (i) Adult and paediatric patients (13 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) (ii) Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) |
DKSH | 12 Oct 2021 |
| Opdivo | Nivolumab | Vial | 10mg/mL | Injection | (i) Malignant pleural mesothelioma (MPM) (ii) Renal Cell Carcinoma (RCC) |
Bristol-Myers Squibb | 20 Oct 2021 |
| Samsca | Tolvaptan | Tablet | 15mg | Oral | Adjunct treatment of volume overload in heart failure | Otsuka Pharmaceuticals | 12 Oct 2021 |
