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New drug approvals - Apr 2017

Product Name	TRAVATAN C EYE DROP SOLUTION 30 MCG/ ML
Active Ingredient	Travoprost
Application type	NDA-2: New strength
Product Registrant	ALCON PTE. LTD.
Date of Approval	10 Apr 2017
Registration No.	SIN15206P
Indications: TRAVATAN C eye drops contains travoprost, a prostaglandin analogue. TRAVATAN C eye drops is indicated for the decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1).

Product Name	KEFENTECH AIR 30 MG/ SHEET
Active Ingredient	Ketoprofen
Application type	NDA-2: New indication
Product Registrant	PHARMAFORTE SINGAPORE PTE. LTD.
Date of Approval	18 Apr 2017
Registration No.	SIN15212P
Indications: Ketoprofen is a medicine that is used to relieve pain and swelling. Kefentech plaster is designed to deliver ketoprofen through the skin to the target area, providing relief for arthritis, tennis elbow, muscle ache, sports and exercise related injuries such as sprains, strains and bruises.

Product Name	JADENU FILM COATED TABLET 90 MG, 180 MG AND 360 MG
Active Ingredient	Deferasirox
Application type	NDA-2: New dosage form and NDA-3: New strength
Product Registrant	NOVARTIS (SINGAPORE) PTE. LTD.
Date of Approval	18 Apr 2017
Registration No.	SIN15213P, SIN15214P and SIN15215P
Indications: Jadenu is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older. Jadenu is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: - in patients with other anaemias, - in patients aged 2 to 5 years, - in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells). Jadenu is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.

Product Name	IKERVIS EYE DROPS, EMULSION 1 MG/ ML
Active Ingredient	Ciclosporin
Application type	NDA-2: New dosage form
Product Registrant	SANTEN PHARMACEUTICAL ASIA PTE. LTD.
Date of Approval	20 Apr 2017
Registration No.	SIN15216P
Indications: Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes (see section 5.1)

Product Name	COTELLIC FILM-COATED TABLET 20 MG
Active Ingredient	Cobimetinib
Application type	NDA-1: New chemical entity
Product Registrant	ROCHE SINGAPORE PTE. LTD.
Date of Approval	21 Apr 2017
Registration No.	SIN15219P
Indications: Cotellic is indicated for use in combination with vemurafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation.

Product Name	KANARB TABLET 60 MG AND 120 MG
Active Ingredient	Fimasartan Potassium
Application type	NDA-1: New chemical entity and NDA-3: New strength
Product Registrant	ZUELLIG PHARMA PTE. LTD.
Date of Approval	24 Apr 2017
Registration No.	SIN15221P and SIN15222P
Indications: Kanarb® Tablets (Fimasartan Potassium Trihydrate) is indicated for the treatment of mild to moderate essential hypertension.

Product Name	REPATHA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 140 MG/ ML REPATHA SOLUTION FOR INJECTION IN PRE-FILLED AUTOINJECTOR 140 MG/ ML
Active Ingredient	Evolocumab
Application type	NDA-1: New biological entity and NDA-2: New dosage form
Product Registrant	AMGEN SINGAPORE MANUFACTURING PTE. LTD.
Date of Approval	24 Apr 2017
Registration No.	SIN15223P and SIN15224P
Indications: Hypercholesterolaemia and mixed dyslipidaemia Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: · in combination with a statin or statin with other lipid lowering therapies in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or, · alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Homozygous familial hypercholesterolaemia Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.

Product Name	ALECENSA HARD CAPSULE 150 MG
Active Ingredient	Alectinib
Application type	NDA-1: New chemical entity
Product Registrant	ROCHE SINGAPORE PTE. LTD.
Date of Approval	24 Apr 2017
Registration No.	SIN15220P
Indications: Alecensa is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non - small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

Product Name	PRALUENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE AND PEN 75 MG/ ML PRALUENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE AND PEN 150 MG/ ML
Active Ingredient	Alirocumab
Application type	NDA-1: New biological entity and NDA-3: New strength
Product Registrant	SANOFI-AVENTIS SINGAPORE PTE. LTD.
Date of Approval	27 Apr 2017
Registration No.	SIN15228P and SIN15229P
Indications: Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.

Healthcare professional, Therapeutic Products

Published: 30 Apr 2017

New Drug Approvals