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New drug approvals - May 2019

Product Name	XOFLUZA TABLETS 20MG AND 40MG
Active Ingredient	Baloxavir marboxil
Application type	NDA-1: New chemical entity
Product Registrant	ROCHE SINGAPORE PTE LTD
Date of Approval	03/05/2019
Registration No.	SIN15679P and SIN15680P
Indications: Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 12 and above who have been symptomatic for no more than 48 hours (see section 3.1.2 Clinical/ Efficacy Studies). Limitations of Use Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Xofluza (see section 3.1.2 Clinical/Efficacy Studies, Resistance Monitoring during Clinical Development).

Product Name	FASENRA SOLUTION FOR INJECTION 30MG/ML (PRE FILLED SYRINGE)
Active Ingredient	Benralizumab
Application type	NDA-1: New biological entity
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	09/05/2019
Registration No.	SIN15683P
Indications: FASENRA is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.

Product Name	KEVZARA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 150 AND 200MG
Active Ingredient	Sarilumab
Application type	NDA-1: New biological entity NDA-3: New strength
Product Registrant	SANOFI-AVENTIS SINGAPORE PTE LTD
Date of Approval	09/05/2019
Registration No.	SIN15681P and SIN15682P
Indications: KEVZARA® is indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).

Product Name	NEURONOX LYOPHILLISED POWDER FOR INJECTION 100 UNITS/VIAL
Active Ingredient	Clostridium botulinum toxin type A
Application type	NDA-2
Product Registrant	FONDACO PTE LTD
Date of Approval	24/05/2019
Registration No.	SIN15692P
Indications: 1. Neuronox® is indicated for the treatment of essential blepharospasm in patients 18 years of age and older. 2. Neuronox® is indicated for the treatment of equinus foot deformity due to spasticity in pediatric cerebral palsy patients 2 years of age and older. 3. Temporary improvement of serious glabellar lines ranging from moderate to severe associated with corrugators muscle and/or procerus muscle activities in adults over the age of 20 and below the age of 65. 4. Muscle spasticity : Neuronox® is indicated for the treatment of upper limb spasticity associated with stroke in patient 20 years of age and older.

Product Name	MAVENCLAD TABLET 10MG
Active Ingredient	Cladribine
Application type	NDA-1
Product Registrant	MERCK PTE. LTD.
Date of Approval	24/05/2019
Registration No.	SIN15691P
Indications: MAVENCLAD is indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses and to delay the progression of physical disability.

Product Name	ERLEADA FILM-COATED TABLET 60MG
Active Ingredient	Apalutamide
Application type	NDA-1
Product Registrant	JOHNSON & JOHNSON PTE LTD
Date of Approval	27/05/2019
Registration No.	SIN15698P
Indications: ERLEADA™ is indicated for the treatment of patients with non-metastatic, castration-resistant prostate cancer (NM-CRPC) who are at high risk of developing metastatic disease (seeClinical studies).

Product Name	BETADINE ANTISEPTIC LIQIUD 10% W/V
Active Ingredient	Povidone-Iodine 10%
Application type	NDA-2
Product Registrant	MUNDIPHARMA PHARMACEUTICALS PTE LTD
Date of Approval	28/05/2019
Registration No.	SIN15699P
Indications: BETADINE®Antiseptic Liquid is indicated for: · Management of minor wounds, including prevention of infection in burns, cuts, and abrasions · Disinfection for hand hygiene including during periods of infectious disease outbreaks · Disinfection of the skin before an operation

Product Name	PRECEDEX IN 0.9% SODIUM CHLORIDE INJECTION 4MCG/ML
Active Ingredient	Dexmedetomidine Hydrochloride
Application type	NDA-2
Product Registrant	PFIZER PTE LTD
Date of Approval	22/05/2019
Registration No.	SIN15689P
Indications: 1.1 Intensive Care Unit Sedation Precedex™ is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours. Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation. 1.2 Procedural Sedation Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Product Name	AIRTAL FILM COATED TABLETS 100mg
Active Ingredient	Aceclofenac
Application type	NDA-1
Product Registrant	ZUELLIG PHARMA PTE. LTD.
Date of Approval	29/05/2019
Registration No.	SIN15700P
Indications: Aceclofenac (Airtal®) is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

Product Name	TRESIBA FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 100 U/ML TRESIBA FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 200 U/ML
Active Ingredient	Insulin Degludec
Application type	NDA-1/NDA-3
Product Registrant	NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Date of Approval	31/05/2019
Registration No.	SIN15703P SIN15704P
Indications: Treatment of diabetes mellitus in adults and adolescents from the age of 12-17 years.

Product Name	RYZODEG® FLEXTOUCH® SOLUTION FOR INJECTION IN PRE-FILLED PEN 100U/ml
Active Ingredient	Insulin Degludec + Insulin Aspart
Application type	NDA-2
Product Registrant	NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Date of Approval	31/05/2019
Registration No.	SIN15706P
Indications: Treatment of diabetes mellitus in adults and adolescents from the age of 12-17 years.

Product Name	VOSEVI FILM-COATED TABLETS 400MG/100MG/100MG
Active Ingredient	Sofosbuvir + Velpatasvir + Voxilaprevir
Application type	NDA-1
Product Registrant	GILEAD SCIENCES SINGAPORE PTE. LTD
Date of Approval	31/05/2019
Registration No.	SIN15705P
Indications: Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Healthcare professional, Therapeutic Products

Published: 31 May 2019

New Drug Approvals