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New drug approvals - Aug 2019

 

Product Name

GILENYA CAPSULE 0.25MG

Active Ingredient

Fingolimod

Application type

NDA-2: New strength / indication / dosing regimen

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

05/08/2019

Registration No.

SIN15761P

Indications:

Gilenya is indicated as monotherapy for the treatment of adult patients and paediatric patients of 10 years of age and above with the relapsing-remitting form of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the progression of physical disability

 

Product Name

REXULTI FILM-COATED TABLETS 4MG, 3MG, 2MG, 1MG, 0.5MG AND 0.25MG

Active Ingredient

Brexpiprazole

Application type

NDA-1: New chemical entity

NDA-3: New strengths

Product Registrant

LUNDBECK SINGAPORE PTE. LTD.

Date of Approval

05/08/2019

Registration No.

SIN15763P, SIN15764P, SIN15765P, SIN15766P, SIN15767, SIN15768P

Indications:

Brexpiprazole is indicated in adult patients for:

· Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was demonstrated in 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode (see section 5.1). The long-term efficacy of brexpiprazole as adjunctive treatment in MDD has not been established.

· Treatment of schizophrenia (see section 5.1).

Product Name

BERIATE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR INFUSION 250IU/VIAL, 500IU/VIAL

Active Ingredient

Human coagulation factor VIII

Application type

NDA-2: Others (Factor VIII product)

Product Registrant

CSL Behring Pte Ltd

Date of Approval

07/08/2019

Registration No.

SIN15771P, SIN15772P

Indications:

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

This product may be used in the management of acquired factor VIII deficiency.

 

Product Name

SKYCELLFLU QUADRIVALENT PREFILLED SYRINGE

Active Ingredients

Purified inactivated influenza virus surface antigen [A/Christchurch/16/2010, NIB-74xp (H1N1)]

Purified inactivated influenza virus surface antigen [A/HongKong/4801/2014, NYMC X263 (H3N2)]

Purified inactivated influenza virus surface antigen [B/Brisbane/60/2008, NYMC BX-35]

Purified inactivated influenza virus surface antigen [B/Phuket/3073/2013]

Application type

NDA-2: New combination

Product Registrant

AJ BIOLOGICS PTE. LTD.

Date of Approval

16/08/2019

Registration No.

SIN15781P

Indication:Active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine, for adults and children 3 years of age and older.

 

Product Name

VERZENIO FILM-COATED TABLET 50MG, 100MG AND 150MG

Active Ingredient

Abemaciclib

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

ELI LILLY (SINGAPORE) PTE LTD

Date of Approval

26/08/2019

Registration No.

SIN15788P, SIN15789P, SIN15790P

Indications:

Verzenio (abemaciclib) is indicated:

• in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

• in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.


Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals