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

September 2021

  • New drugs approved: 9
  • New drug indications approved: 6

New drugs approved

Product name Active ingredient(s) Dosage Form Strength of dosage form Route of Administration Indication(s) Pharmaceutical company Approval Date
Inhixa Enoxaparin Pre-Filled Syringe/Pen 80mg/0.8mL Injection (i) Prevention of VTE
(ii) Treatment of DVT
(iii) Prevention of thrombus formation in extracorporeal circulation during haemodialysis
(iv) Treatment of unstable angina, MI (with aspirin)
(v) Treatment of STEMI with a thrombolytic agent
HC Healthcare 22 Sep 2021
Vyepti Eptinezumab Vial 100mg/mL Injection Prophylaxis of migraine in adults Lundbeck Singapore 16 Sep 2021
Dayvigo Lemborexant Tablet 5mg, 10mg Oral Treatment of adult patients with insomnia, characterised by difficulties with sleep onset and/or sleep maintenance Eisai 15 Sep 2021
Zepzelca Lurbinectedin Vial 4mg Injection Adult patients with metastatic small cell lung cancer (SCLC) who have progressed after prior platinum-containing therapy (*provisional approval) Specialised Therapeutics Asia 21 Sep 2021
Proveblue Methylene blue Ampoule 5mg/mL Injection (i) Treatment of drug and chemical products-induced methaemoglobinaemia
(ii) Dye in diagnostic procedures such as fistula detection
(iii) Delineation of certain body tissues during surgery
Pharm-D Singapore 03 Sep 2021
Ibrance Palbociclib Tablet 75mg, 100mg, 125mg Oral Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer Pfizer 15 Sep 2021
Takipril Prilocaine Hydrochloride Ampoule 20mg/mL Injection Spinal anaesthesia in short-term surgical procedures B. Braun Singapore 17 Sep 2021
Yupelri Revefenacin Vial 175mcg/3mL Inhalation Maintenance treatment of patients with COPD Mylan Pharmaceuticals 28 Sep 2021
Cosentyx Secukinumab Pre-Filled Syringe/Pen 75mg/0.5mL Injection Moderate to severe plaque psoriasis in patients 6 years and older Novartis 01 Sep 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
Eraxis Anidulafungin Vial 100mg Injection Treatment of invasive candidiasis in adult and in paediatric patients one month and older Pfizer 22 Sep 2021
Cabometyx Cabozantinib Tablet 20mg, 40mg, 60mg Oral First-line treatment of advanced renal cell carcinoma in adults Ipsen 06 Sep 2021
Vigamox Moxifloxacin Drops (Eye/Ear) 0.50% Ophthalmic Treatment of bacterial conjunctivitis, blepharitis, dacryocystitis, hordeolum, tarsadenitis, keratitis (including corneal ulcer) caused by susceptible strains, as well as preoperative and postoperative prophylaxis Novartis 22 Sep 2021
Cosentyx Secukinumab Pre-Filled Syringe/Pen 150mg/mL Injection Moderate to severe plaque psoriasis in patients 6 years and older Novartis 01 Sep 2021
Cosentyx Secukinumab Vial 150mg Injection Moderate to severe plaque psoriasis in patients 6 years and older Novartis 01 Sep 2021
Pamorelin Triptorelin Vial 3.75mg Injection Adjuvant treatment of early stage breast cancer in women:
– In combination with tamoxifen or an aromatase inhibitor
– Hormone receptor positive
– High risk of recurrence
– Confirmed as premenopausal
– Completion of chemotherapy
Orient Europharma 06 Sep 2021

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