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
NEW DRUG APPROVAL
Product Name | |
Active Ingredient | telmisartan and amlodipine |
Licence Holder | BOEHRINGER INGELHEIM SINGAPORE PTE LTD |
Date of Approval | 9 Sep 2011 |
Licence No. | SIN14011P |
Indications: Treatment of essential hypertension. Replacement Therapy Patients receiving telmisartan and amlodipine from separate tablets may instead receive TWYNSTA containing the same component doses. Add on therapy TWYNSTA is indicated in patients whose blood pressure is not adequately controlled on telmisartan or amlodipine monotherapy. Initial therapy TWYNSTA may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of TWYNSTA as initial therapy for hypertension should be based on an assessment of potential benefits and risks. | |
Product Name | |
Active Ingredient | hydroxyethylstarch |
Licence Holder | B BRAUN SINGAPORE PTE LTD |
Date of Approval | 21 Sep 2011 |
Licence No. | SIN14017P |
Indications: Treatment of imminent or manifest hypovolaemia and shock. | |
Product Name | |
Active Ingredient | besifloxacin |
Licence Holder | DKSH SINGAPORE PTE LTD |
Date of Approval | 23 Sep 2011 |
Licence No. | SIN14021P |
Indications: Besivance® (besifloxacin ophthalmic suspension) 0.6%, is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: CDC coryneform group G Corynebacterium pseudodiphtheriticum* Corynebacterium striatum* Haemophilus influenzae Moraxella lacunata* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus hominis* Staphylococcus lugdunensis* Streptococcus mitis group Streptococcus oralis Streptococcus pneumoniae Streptococcus salivarius* *Efficacy for this organism was studied in fewer than 10 infections | |
Product Name | |
Active Ingredient | pazopanib |
Licence Holder | GLAXOSMITHKLINE PTE LTD |
Date of Approval | 23 Sep 2011 |
Licence No. | SIN14023P |
Indications: Votrient is indicated for the first line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. | |
Product Name | |
Active Ingredient | denosumab |
Licence Holder | GLAXOSMITHKLINE PTE LTD |
Date of Approval | 27 Sep 2011 |
Licence No. | SIN14024P |
Indications: Treatment of postmenopausal women with osteoporosis at high risk for fracture PROLIA is indicated for the treatment of postmenopausal women with osteoporosis at high risk of fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other osteoporosis therapy. In postmenopausal women with osteoporosis, PROLIA reduces the incidence of vertebral, nonvertebral, and hip fractures. | |
NEW INDICATION APPROVAL
Product Name | |
Active Ingredient | entecavir |
Licence Holder | BRISTOL-MYERS SQUIBB (SINGAPORE) PTE LTD |
Date of Approval | 8 Sep 2011 |
Indications: BARACLUDE® (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. The following points should be considered when initiating therapy with BARACLUDE: - This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease [see Clinical Studies (12)]. - Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease [see Adverse Reactions (5) and Clinical Studies (12.1)]. - Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy [see Warnings and Precautions (4.2) and Clinical Studies (12.1)]. | |
Product Name | |
Active Ingredient | leuprorelin acetate |
Licence Holder | ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED |
Date of Approval | 12 Sep 2011 |
Indications: Endometriosis Leuprorelin acetate for depot suspension is indicated in the treatment of endometriosis for a period of six months. It can be used as sole therapy or as an adjunct to surgery. Leuprorelin acetate for depot suspension with norethindrone acetate 5 mg daily as add-back is also indicated for treatment of endometriosis for a period of six months. | |
Product Name | |
Active Ingredient | estradiol and dienogest |
Licence Holder | BAYER (SOUTH EAST ASIA) PTE LTD |
Date of Approval | 19 Sep 2011 |
Indications: Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception. | |
Product Name | |
Active Ingredient | ribavirin |
Licence Holder | SOL LIMITED (SINGAPORE BRANCH) |
Date of Approval | 23 Sep 2011 |
Indications: REBETOL* Capsules are indicated in combination with interferon alfa-2b for the treatment of chronic hepatitis C in adult patients previously untreated with alpha interferon or who have subsequently relapsed following alpha interferon therapy. REBETOL* Capsules are indicated in combination with peginterferon alfa-2b for the treatment of chronic hepatitis C in naïve, relapse and nonresponder patients. This combination of peginterferon alfa-2b and REBETOL Capsules is also indicated in the treatment of patients with chronic hepatitis C who are co-infected with clinically stable HIV. Patients must be 18 years of age or older and have compensated liver disease including those with histologic evidence of cirrhosis (Child-Pugh class A) and those with normal or abnormal ALT. See the prescribing information for peginterferon alfa-2b or interferon alfa-2b for information on its actions. | |
Product Name | |
Active Ingredient | ranibizumab |
Licence Holder | NORVATIS (SINGAPORE) PTE LTD |
Date of Approval | 28 Sep 2011 |
Indications: Lucentis is indicated for: - the treatment of visual impairment due to diabetic macular edema (DME). - the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). | |
Product Name | CRAVIT TABLET 250MG AND 500MG |
Active Ingredient | levofloxacin |
Licence Holder | KYOWA HAKKO BIO SINGAPORE PTE LTD |
Date of Approval | 30 Sep 2011 |
Indications: 1. Nosocomial pneumonia due to methicillin‐susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti‐pseudomonal β‐lactam is recommended. 2. Chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis. | |
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