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.
November 2021
- New drugs approved: 7
- New drug indications approved: 7
New drugs approved
| Product name | Active ingredient(s) | Dosage Form | Strength of dosage form | Route of Administration | Indication(s) | Pharmaceutical company | Approval Date |
| Hulio | Adalimumab | Pre-Filled Syringe/Pen | 40mg/0.8mL | Injection | (i) Rheumatoid Arthritis (adults) (ii) Psoriatic Arthritis (adults) (iii) Ankylosing Spondylitis (adults) (iv) Crohn’s Disease (adults and paediatrics) (v) Ulcerative Colitis (adults) (vi) Plaque Psoriasis (adults and paediatrics) (vii) Hidradenitis Suppurativa (adults and adolescent) (viii) Uveitis (adults and paediatrics) (ix) Idiopathic Arthritis (paedictrics) (x) Enthesitis-Related Arthritis (paediatrics) |
Mylan Pharmaceuticals | 02 Nov 2021 |
| Slinda | Drospirenone | Tablet | 4mg | Oral | Oral contraception | Intega | 01 Nov 2021 |
| Kerendia | Finerenone | Tablet | 10mg, 20mg | Oral | In adults with CKD and albuminuria associated with T2DM – to reduce risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure | Bayer | 25 Nov 2021 |
| Cosentyx | Secukinumab | Pre-Filled Syringe/Pen | 300mg/2mL | Injection | (i) Plaque psoriasis – moderate to severe plaque psoriasis in patients 6 years and older (ii) Psoriatic arthritis – active psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate (iii) Axial spondyloarthritis (axSpA) with or without radiographic damage (iv) Ankylosing spondylitis (AS)/ axSpA with radiographic damage (v) Non-radiographic axial spondyloarthritis (nr-axSpA) / axSpA without radiographic damage |
Novartis | 02 Nov 2021 |
| Tepmetko | Tepotinib | Tablet | 225mg | Oral | Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) | Merck | 25 Nov 2021 |
| Domide | Thalidomide | Capsule | 50mg | Oral | Untreated multiple myeloma | Pharm-D Singapore | 02 Nov 2021 |
| Canhera | Trastuzumab | Vial | 440mg | Injection | (i) Metastatic Breast Cancer (MBC) (ii) Eaarly Breast Cancer (EBC) (iii) Metastatic Gastric Cancer (MGC) |
Pharma To Market | 25 Nov 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 |
| Olumiant | Baricitinib | Tablet | 2mg, 4mg | Oral | Treatment of moderate to severe atopic dermatitis in adult patients | DKSH | 10 Nov 2021 |
| Benlysta | Belimumab | Vial | 120mg, 400mg | Injection | Treatment of active lupus nephritis in adult patients | GlaxoSmithKline | 15 Nov 2021 |
| Plavix | Clopidogrel | Tablet | 75mg | Oral | In combination with aspirin – moderate to high-risk TIA (ABCD2 score ≥4) or minor IS (NIHSS ≤3) within 24 hours of either the TIA or IS event | Sanofi-Aventis | 15 Nov 2021 |
| Boostrix | Diphtheria toxoid, Pertussis toxoid, Tetanus toxoid | Pre-Filled Syringe/Pen | NA | Injection | Booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards | GlaxoSmithKline | 23 Nov 2021 |
| Boostrix Polio | Diphtheria toxoid, Pertussis toxoid, Tetanus toxoid, Inactivated polio virus | Pre-Filled Syringe/Pen | NA | Injection | Booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of three years onwards | GlaxoSmithKline | 23 Nov 2021 |
| Lorviqua | Lorlatinib | Tablet | 25mg, 100mg | Oral | First line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) | Pfizer | 19 Nov 2021 |
| Rinvoq | Upadacitinib | Tablet (Sustained Release) | 15mg | Oral | (i) Psoriatic arthritis – adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs (ii) Ankylosing spondylitis – treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy |
Abbvie | 19 Nov 2021 |
