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Singapore’s HSA New Drugs and Indications Approval – Nov 2021

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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.

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

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