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June 2011

This report lists applications approved during the period as indicated above.  It includes first new drug application of an innovator product and first combination, dosage form or new usage of an innovator product.  The list also includes new indication approved for an existing medicinal product.

 

NEW DRUG APPROVAL

PRODUCT NAME
AZOREN FILM-COATED TABLET 20MG/5MG
BIOTHRAX (ANTHRAX VACCINE ABSORBED) SUSPENION FOR INJECTION 50µG/DOSE
INVEGA SUSTENNA PROLONGED RELEASE SUSPENSION FOR IM INJECTION 25MG/0.25ML
REBIF SOLUTION FOR INJECTION IN CARTRIDGE 22MCG/0.5ML
ELLA TABLET 30MG

NEW INDICATION APPROVAL

PRODUCT NAME
JANUVIA TABLETS 25, 50 AND 100MG
JANUMET TABLETS 50/500, 50/850 AND 50/1000MG/MG
VALCYTE TABLET 450MG

 

NEW DRUG APPROVAL

Product Name
AZOREN FILM-COATED TABLET 20MG/5MG
Active Ingredient
olmesartan medoxomil/ amlodipine besylate
Licence Holder
PFIZER PTE LTD
Date of Approval
6 Jun 2011
Licence No.
SIN13964P
Indications:
Treatment of essential hypertension.
Azoren is indicated in patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy.

 

Product Name
BIOTHRAX (ANTHRAX VACCINE ADSORBED) SUSPENSION FOR INJECTION 50µG/DOSE
Active Ingredient
anthrax antigen protein
Licence Holder
EMERGENT SALES AND MARKETING SINGAPORE PTE LTD
Date of Approval
8 Jun 2011
Licence No.
SIN13967P
Indications:
BioThrax is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons between 18 and 65 years of age whose occupation or other activities place them at high risk of exposure. Since the risk of anthrax infection in the general population is low, routine immunization is not recommended.
The safety and efficacy of BioThrax in a post-exposure setting have not been established.

 

Product Name
INVEGA SUSTENNA PROLONGED RELEASE SUSPENSION FOR IM INJECTION 25MG/0.25ML
Active Ingredient
paliperidone palmitate
Licence Holder
JOHNSON & JOHNSON PTE LTD
Date of Approval
13 Jun 2011
Licence No.
SIN13968P
Indications:
INVEGA Sustenna is indicated for the treatment of schizophrenia and for the prevention of recurrence of symptoms of schizophrenia.

 

Product Name
REBIF SOLUTION FOR INJECTION IN CARTRIDGE 22MCG/0.5ML
Active Ingredient
interferon beta-1a
Licence Holder
MERCK PTE LTD
Date of Approval
17 Jun 2011
Licence No.
SIN13974P
Indications:
Rebif is indicated for the treatment of relapsing multiple sclerosis.
In clinical trials, this was characterised by two or more acute exacerbations in the previous two years.
Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity.

 

Product Name
ELLA TABLET 30MG
Active Ingredient
ulipristal acetate
Licence Holder
HYPHENS PHARMA PTE LTD
Date of Approval
21 Jun 2011
Licence No.
SIN13979P
Indications:
Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

 

NEW INDICATION APPROVAL

Product Name
JANUVIA TABLETS 25, 50 AND 100MG
Active Ingredient
sitagliptin phosphate
Licence Holder
MSD SINGAPORE
Date of Approval
13 Jun 2011
Indications:
Combination with Insulin
JANUVIA is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control

 

Product Name
JANUMET TABLETS 50/500, 50/850 AND 50/1000MG/MG
Active Ingredient
sitagliptin phosphate/metformin hydrochloride
Licence Holder
MSD SINGAPORE
Date of Approval
13 Jun 2011
Indications:
JANUMET is indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycemic control in patients when insulin and metformin alone do not provide adequate glycemic control.

 

Product Name
VALCYTE TABLET 450MG
Active Ingredient
valganciclovir
Licence Holder
ROCHE SINGAPORE PTE LTD
Date of Approval
23 Jun 2011
Indications:
For the prevention of CMV disease in heart, kidney, and kidney-pancreas transplantation
For kidney transplant patients, the recommended dose is 900 mg (two 450 mg tablets) once daily with food starting within 10 days of transplantation until 100 days post-transplantation. Prophylaxis may be continued until 200 days post-transplantation (See 3.4 Special Warnings and Special Precautions for Use, 3.8 Undesirable Effects and 4.1.2 Efficacy/Clinical Studies).
For patients who have received a heart, or kidney-pancreas transplant, the recommended dose is 900 mg (two 450 mg tablets) once daily with food starting within 10 days of transplantation until 100 days post-transplantation.


Last updated on 08 Jan 2013 13:16:50