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New drug indication approval - October 2021

Product Name	FIASP FLEXTOUCH 100U/ML FIASP SOLUTION FOR INJECTION IN VIAL 100U/ML
Active Ingredient	Insulin aspart
Product Registrant	NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Date of Approval	01/10/2021
Indications: Treatment of diabetes mellitus in adults,adolescents and children aged 2 years and above.

Product Name	LATUDA TABLET 40MG, LATUDA TABLET 80MG
Active Ingredient	Lurasidone hydrochloride
Product Registrant	DKSH SINGAPORE PTE. LTD.
Date of Approval	12/10/2021
Indications: LATUDA is indicated for: • Monotherapy treatment of adult and pediatric patients (13 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression). • Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression).

Product Name	SAMSCA TABLETS 15MG
Active Ingredient	Tolvaptan
Product Registrant	OTSUKA PHARMACEUTICALS (SINGAPORE)PTE LTD
Date of Approval	12/10/2021
Indications: Adjunct Treatment of Volume Overload in Heart Failure Volume overload in heart failure when adequate response is not obtained with other diuretics (e.g., loop diuretics). Limitations of Use: When conditions or symptoms due to volume overload are resolved, administration of SAMSCA should be discontinued. The efficacy and safety of SAMSCA for maintenance treatment following resolution have not been established. In a clinical study, 15 mg tolvaptan has been associated with worse clinical outcomes vs placebo when rated at 6 months (last visit).

Product Name	XOFLUZA FILM COATED TABLETS 20MG XOFLUZA FILM COATED TABLETS 40MG
Active Ingredient	Baloxavir Marboxil
Product Registrant	ROCHE SINGAPORE PTE. LTD.
Date of Approval	19/10/2021
Indications: Treatment of Influenza Xofluza is indicated for the treatment of acute uncomplicated influenza in patients aged 12 and above who have been symptomatic for no more than 48 hours and who are: otherwise healthy, or at high risk of developing influenza-related complications (see section 3.1.2 Clinical/ Efficacy Studies). Prophylaxis of Influenza Xofluza is indicated for the post-exposure prophylaxis of influenza in individuals aged 12 and above.

Product Name	KYPROLIS POWDER FOR SOLUTION FOR INFUSION 60MG/VIAL; 30 MG/VIAL
Active Ingredient	Carfilzomib
Product Registrant	Amgen Biotechnology Singapore Pte Ltd
Date of Approval	20/10/2021
Indications: Kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with: Daratumumab and dexamethasone.

Product Name	DARZALEX CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/5ML, 400MG/20ML
Active Ingredient	Daratumumab
Product Registrant	Johnson & Johnson Pte Ltd
Date of Approval	20/10/2021
Indications: DARZALEX® is indicated for the treatment of patients with multiple myeloma: in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

Product Name	OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML
Active Ingredient	Nivolumab
Product Registrant	Bristol Myers Squibb
Date of Approval	20/10/2021
Indications: Malignant pleural mesothelioma (MPM) OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Renal Cell Carcinoma (RCC) OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (see section 5.1).

Product Name	JARDIANCE FILM COATED TABLETS 10MG
Active Ingredient	Empagliflozin
Product Registrant	Boehringer Ingelheim
Date of Approval	28/10/2021
Indications: Heart failure (HF) JARDIANCE is indicated in adult patients with heart failure (NYHA class II-IV) and reduced ejection fraction, with or without type 2 diabetes mellitus to reduce the risk of cardiovascular death and hospitalization for heart failure (see clinical trials)

Product Name	TALTZ SOLUTION FOR INJECTION IN PRE-FILLED PEN 80 MG/ML
Active Ingredient	Ixekizumab
Product Registrant	DKSH Singapore Pte Ltd
Date of Approval	28/10/2021
Indications: Paediatric plaque psoriasis Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and adolescents who are candidates for systemic therapy.

Product Name	FORXIGA TABLETS 5MG, 10MG
Active Ingredient	Dapagliflozin
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	29/10/2021
Indications: Chronic kidney disease FORXIGA is indicated as an adjunct to standard therapy to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular (CV) death in adults with chronic kidney disease at risk of progression.

Healthcare professional, Industry member, Therapeutic Products

Published: 22 Oct 2021

New Drug Indication Approvals