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Singapore’s HSA New Drugs and Indications Approval – Dec 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.

December 2021

  • New drugs approved: 3
  • New drug indications approved: 2

New drugs approved

Product name Active ingredient(s) Dosage Form Strength of dosage form Route of Administration Indication(s) Pharmaceutical company Approval Date
Oncaspar Pegaspargase Vial 750 U/mL Injection A component of anti-neoplastic combination therapy in acute lymphoblastic leukaemia (ALL) Servier 27 Dec 2022
Nufilong Pegfilgrastim Pre-Filled Syringe/Pen 6mg/0.6mL Injection Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Pharma To Market 07 Dec 2022
Comirnaty Tozinameran Vial 30mcg, 10mcg Injection Active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 5 years of age and older BioNTech Pharmaceuticals Asia Pacific 10 Dec 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
Humira Adalimumab Multiple Multiple Injection Paediatric Ulcerative Colitis AbbVie 22 Dec 2022
Spravato Esketamine Vial 28mg per vial Inhalation Indicated in adults with a moderate to severe episode of Major Depressive Disorder, as acute short-term treatment, for the rapid reduction of depressive symptoms Johnson & Johnson 08 Dec 2022

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