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 |
