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    Home»Access1»Singapore’s HSA New Drugs and Indications Approval – Apr 2021
    Access1

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

    Sian LinBy Sian LinMay 25, 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.

    April 2021

    • New drugs approved: 8
    • New drug indications approved: 3

    New drugs approved

    Product name Active ingredient(s) Dosage Form Strength of dosage form Route of Administration Indication(s) Pharmaceutical company Approval Date
    Mvasi Bevacizumab Vial 25mg/mL Injection Metastatic carcinoma of the colon or rectum (mCRC)

    Metastatic breast cancer (mBC)

    Non-Small Cell Lung Cancer (NSCLC)

    Malignant Glioma (WHO Grade IV) – Glioblastoma

    Advanced and/or metastatic Renal Cell Cancer (mRCC)

    Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

    Cervical Cancer

    Amgen Biotechnology 10 Apr 2021
    Crysvita Burosumab Vial 10mg/mL

    20mg/mL

    30mg/mL

    Injection Treatment of X-linked hypophosphatemia Kyowa Kirin 30 Apr 2021
    Veraseal Human Fibrinogen/ Human Thrombin Solution (Topical) 80 IU/mL/ 500 mg/mL Topical Improvement of haemostasis

    Suture support: in vascular surgery

    Grifols 01 Apr 2021
    Enerzair Breezhaler Indacaterol/ Glycopyrronium/ Mometasone furoate Inhaler 150mcg/ 50mcg/ 160mcg Inhalation Maintenance treatment of asthma

    Reduce asthma exacerbations

    Novartis 14 Apr 2021
    Atectura Breezhaler Indacaterol/ Mometasone furoate Inhaler 150mcg/ 80mcg

    150mcg/ 160mcg

    150mcg/ 320mcg

    Inhalation Maintenance treatment of asthma Novartis 07 Apr 2021
    Nucala Mepolizumab Pre-Filled Syringe/Pen 100mg/mL Injection Severe eosinophilic asthma

    Eosinophilic Granulomatosis with Polyangiitis (EGPA)

    GlaxoSmithKline 27 Apr 2021
    Eybelis Omidenepag Isopropyl Drops (Eye/Ear) 0.002% Ophthalmic Open-angle glaucoma or ocular hypertension – reduction of elevated intraocular pressure Santen Pharmaceutical 07 Apr 2021
    Ozempic Semaglutide Pre-Filled Syringe/Pen 0.25mg

    0.5mg

    1mg

    Injection Insufficiently controlled type 2 diabetes mellitus Novo Nordisk Pharma 21 Apr 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
    Lynparza Olaparib Tablet 100mg

    150mg

    Oral Advanced (FIGO stages III and IV) high grade epithelial ovarian, fallopian tube or primary peritoneal cancer AstraZeneca 28 Apr 2021
    Ibrance Palbociclib Capsule 75mg

    100mg

    125mg

    Oral Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer Pfizer 06 Apr 2021
    Stelara Ustekinumab Pre-Filled Syringe/Pen 45mg/0.5mL

    90mg/1mL

    Injection Paediatric patients (6 years and older) with moderate to severe plaque psoriasis Johnson & Johnson 27 Apr 2021
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    Sian Lin

    This writer is part of the Medical Channel Asia editorial team. The Medical Channel Asia editorial team brings together a diverse group of seasoned journalists, pharmacists, and doctor to deliver breaking news, insightful analysis, informed opinions, and thought-provoking perspectives into the world of healthcare.

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