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New drug indication approval - May 2020

Product Name	VICTOZA® SOLUTION FOR INJECTION IN PRE-FILLED PEN 6MG/ML
Active Ingredient	Liraglutide
Product Registrant	NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Date of Approval	08 May 2020
Indications: Victoza® is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes (see Pharmacodynamic properties – Clinical efficacy and safety section).

Product Name	REVOLADE TABLET 25MG AND 50MG
Active Ingredient	Eltrombopag olamine
Product Registrant	NOVARTIS (SINGAPORE) PTE LTD
Date of Approval	15/05/2020
Indications: Revolade is indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and adolescent patients 12 years and older with severe aplastic anemia.

Product Name	XOLAIR POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 75 AND 150MG
Active Ingredient	Omalizumab
Product Registrant	NOVARTIS (SINGAPORE) PTE LTD
Date of Approval	22/05/2020
Indications: Children (6 to < 12 years of age) Xolair is indicated as add-on therapy to improve asthma control with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Product Name	OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10 MG/ML
Active Ingredient	Nivolumab
Product Registrant	BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
Date of Approval	27/05/2020
Indications: OPDIVO, in combination with ipilimumab and 2 cycles of platinum-based chemotherapy, is indicated for the first-line treatment of metastatic or recurrent NSCLC in adult patients with no EGFR or ALK genomic tumor mutations. *Evaluated as part of Project Orbis

Product Name	CALQUENCE HARD CAPSULES 100MG
Active Ingredient	Acalabrutinib
Product Registrant	ASTRAZENECA PTE LTD
Date of Approval	28/05/2020
Indications: CALQUENCE (acalabrutinib) is indicated: • in combination with obinutuzumab or as monotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). • as monotherapy for the treatment of patients with CLL/SLL who have received at least one prior therapy. *Evaluated as part of Project Orbis

Product Name	SYMBICORT RAPIHALER SUSPENSION FOR INHALATION 80/2.25 MCG/ACTUATION
Active Ingredient	Budesonide micronized, Formoterol
Product Registrant	AstraZeneca Singapore Pte Ltd
Date of Approval	28/05/2020
Indications: Asthma Symbicort Rapihaler is indicated in the treatment of asthma to achieve overall asthma control, including the prevention and relief of symptoms as well as the reduction of the risk of exacerbations. Symbicort Rapihaler is indicated for treatment of asthma, where the use of inhaled corticosteroids is appropriate.

Healthcare professional, Industry member, Therapeutic Products

Published: 31 May 2020

New Drug Indication Approvals