PRINT THIS PAGE |
||
|
|
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
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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 | |
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