New drug approvals - Mar 2021

  • Please click here for a list of summary reports of benefit-risk assessments. 

Product Name

NOVOEIGHT POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 250IU/VIAL, 500IU/VIAL AND 1000IU/VIAL

Active Ingredient

Turoctocog Alfa

Application type

NDA-1: New biological entity

NDA-3: New strength

Product Registrant

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Date of Approval

01/03/2021

Registration No.

SIN16109P, SIN16110P, SIN16111P

Indications:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

NovoEight® does not contain Willebrand factor and is not indicated in von Willebrand disease.

NovoEight® can be used for all age groups.

 

Product Name

XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 75MG/0.5ML AND 150MG/1.0ML

Active Ingredient

Omalizumab

Application type

NDA-2: New dosage form

NDA-3: New strength

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

04/03/2021

Registration No.

SIN16115P and SIN16116P

Indications:

Allergic Asthma

Xolair treatment should only be considered for patients with convincing IgE mediated asthma (see section 4.2).

Adults and adolescents (12 years of age and above)

Xolair is indicated as add-on therapy to improve asthma control in adult and adolescent (12 years of age and above) with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as 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.

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.

Chronic rhinosinusitis with nasal polyps (CRSwNP)

Xolair is indicated as an add-on therapy to intranasal corticosteroids for the treatment of CRSwNP in adults (18 years of age and above) with inadequate response to intranasal corticosteroids.

Chronic Spontaneous Urticaria (CSU)

Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.

 

Product Name

ANSTO-SODIUM IODIDE [131I] THERAPY CAPSULE VIAL (50 MBQ TO 6000 MBQ)

Active Ingredient

Sodium Iodide [I-131] 50 to 6000 MBq

Application type

NDA-2: New strength

Product Registrant

Transmedic Pte Ltd

Date of Approval

08/03/2021

Registration No.

SIN16117P

Indications:

Sodium Iodide (131I) Therapy Capsules are indicated in the treatment of hyperthyroidism, and the detection and ablation of residual functioning thyroid tissue in differentiated thyroid carcinoma.

 

Product Name

SIMPONI SOLUTION FOR INJECTION IN PRE-FILLED PEN 45MG/0.45ML

Active Ingredient

Golimumab

Application type

NDA-2: New strength

Product Registrant

Johnson & Johnson Pte. Ltd.

Date of Approval

09/03/2021

Registration No.

SIN16118P

Indications:

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis (pJIA)

Simponi in combination with methotrexate (MTX) is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.

 

Product Name

ABILIFY TABLET 2MG

ABILIFY ORAL SOLUTION 1MG/ML

Active Ingredient

Aripiprazole

Application type

NDA-2: New strength

NDA-2: New dosage form

Product Registrant

OTSUKA PHARMACEUTICALS (SINGAPORE) PTE. LTD.

Date of Approval

10/03/2021

Registration No.

SIN16119P

SIN16120P

Indications:

Schizophrenia

ABILIFY is indicated for the treatment of schizophrenia. The efficacy of ABILIFY in the treatment of schizophrenia was established in four short-term (4- and 6-week) controlled trials in adults and one 6-week trial in paediatrics (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to paediatrics [see CLINICAL STUDIES (13.1)]. The physician who elects to use ABILIFY for extended periods should periodically re-evaluate the long- term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION (2)].

Bipolar I Disorder

ABILIFY is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder and for maintaining stability or preventing recurrence, as monotherapy in adults and in adolescents aged 13 years and older, and as an adjunct to lithium or valproate in adults.

The efficacy of ABILIFY as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in paediatric patients. Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults [see CLINICAL STUDIES (13.2)].

Maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults [see CLINICAL STUDIES (13.2)]. Physicians who elect to use ABILIFY for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION (2)].

Adjunctive Treatment of Major Depressive Disorder

ABILIFY is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).

Efficacy was established in three 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode [see CLINICAL STUDIES (13.3)].

Irritability Associated with Autistic Disorder

ABILIFY is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in paediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) [see CLINICAL STUDIES (13.4)].

The efficacy of ABILIFY for the maintenance treatment of irritability associated with autistic disorder was not established.

Tourette’s Disorder

ABILIFY is indicated for the treatment of Tourette’s disorder. Efficacy was established in one 8-week (aged 7 to 17 years) and one 10-week (aged 6 to 18 years) placebo-controlled trial in paediatric patients with Tourette’s disorder [see CLINICAL STUDIES (13.5)].

 

Product Name

DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 200 mg/1.14ml

Active Ingredient

Dupilumab

Application type

NDA-2: New strength, new indication and dosing regimen

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

15 Mar 2021

Registration No.

SIN16121P

Indications:

DUPIXENT is indicated for the following diseases:

1.1 Atopic Dermatitis

DUPIXENT is indicated for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis who require chronic treatment and whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

DUPIXENT can be used with or without topical corticosteroids.

1.2 Asthma

DUPIXENT is indicated in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by elevated blood eosinophils and/or elevated FeNO.

DUPIXENT is indicated as maintenance therapy for oral corticosteroid-dependent asthma.

 

Product Name

PANADOL CHILDREN SUSPENSION 250MG/5ML

Active Ingredient

Paracetamol

Application type

NDA-2: New dosage form

Product Registrant

GSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.

Date of Approval

30/03/2021

Registration No.

SIN16142P

Indications:

Children’s Panadol Suspension is indicated for the relief of fever and pain associated with headache, teething, toothache, earache, immunisation, symptoms of cold and flu.

 

Product Name

SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION

SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE-FREE EMULSION FOR INFUSION

Active Ingredient

SMOFLipid 20% (SIN13246P)

Amino acids ± electrolytes

Glucose

Application type

NDA-2: New strength

Product Registrant

Fresenius Kabi (Singapore) Pte Ltd

Date of Approval

24 Mar 2021

Registration No.

SIN16135P

SIN16136P

Indications:

Parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.


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Published:

New Drug Approvals