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.
February 2022
- New drugs approved: 1
- New drug indications approved: 4
New drugs approved
| Product name | Active ingredient(s) | Dosage Form | Strength of dosage form | Route of Administration | Indication(s) | Pharmaceutical company | Approval Date |
| Luconac | Luliconazole | Solution (Topical) | 5% w/w | Topical | Topical treatment in adult patients with mild to moderate tinea unguium with symptoms of distal and lateral subungual onychomycosis | Zuellig Pharma | 14 Feb 2022 |
New drug indications approved
| Product name | Active ingredient(s) | Dosage Form | Strength of dosage form | Route of Administration | Indication(s) | Pharmaceutical company | Approval Date |
| Darzalex | Daratumumab | Vial | 1800mg/15mL | Injection | Treatment of newly diagnosed patients with light chain (AL) amyloidosis, in combination with bortezomib, cyclophosphamide and dexamethasone | Johnson & Johnson | 04 Feb 2022 |
| Opdivo | Nivolumab | Vial | 10mg/mL | Injection | Treatment of patients with unresectable HER2 negative advanced or metastatic gastric cancer, gastroesophageal junction cancer, or oesophageal adenocarcinoma | Bristol-Myers Squibb | 16 Feb 2022 |
| Keytruda | Pembrolizumab | Vial | 25mg/mL | Injection | First-line treatment of patients with locally advanced or metastatic carcinoma of the esophagus or HER2-negative gastroesophageal junction (GEJ) adenocarcinoma, not amendable to surgical resection or definitive chemoradiation | MSD Pharma | 04 Feb 2022 |
| Xarelto | Rivaroxaban | Tablet | 15mg, 20mg | Oral | Paediatric population (children and adolescents aged less than 18 years): treatment and prevention of VTE after at least 5 days of initial parenteral anticoagulation treatment: (i) 15mg: weighing between 30 to 50kg (ii) 20mg: weighing more than 50kg |
Bayer | 21 Feb 2022 |
