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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:

New Drug Approvals