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Singapore’s HSA New Drugs and Indications Approval – Feb 2022

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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

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