New Drug Indication Approval - Oct 2019
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Product Name
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INVOKANA FILM COATED TABLETS 100MG, 300MG
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Active Ingredient
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Canagliflozin |
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Product Registrant
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JOHNSON & JOHNSON PTE LTD |
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Date of Approval
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09/10/2019 |
| Indications: INVOKANA™ is indicated, as an adjunct to diet, exercise and standard care therapy, to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) who have inadequate glycemic control. |
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Product Name
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IKERVIS EYE DROPS, EMULSION 1MG/ML
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Active Ingredient
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Ciclosporin |
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Product Registrant
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SANTEN PHARMACEUTICAL ASIA PTE. LTD. |
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Date of Approval
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09/10/2019 |
| Indications: Treatment of severe vernal keratoconjunctivitis (VKC) in children and adolescents from 4 to 18 years old. |
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Product Name
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SYMBICORT TURBUHALER 160/4.5 MCG/DOSE
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Active Ingredient
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Budesonide, Formoterol fumarate dihydrate
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Product Registrant
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ASTRAZENECA SINGAPORE PTE LTD |
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Date of Approval
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9/10/2019 |
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Indications: Symbicort Turbuhaler is indicated in the treatment of asthma to achieve overall asthma control, including the prevention and relief of symptoms as well as the reduction of the risk of exacerbations.
Symbicort Turbuhaler is indicated for treatment of asthma, where the use of inhaled corticosteroids is appropriate.
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Product Name
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PRALUENT SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE AND PEN 75MG/ML & 150MG/ML
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Active Ingredient
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Alirocumab |
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Product Registrant
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SANOFI-AVENTIS SINGAPORE PTE. LTD. |
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Date of Approval
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09/10/2019 |
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Indications:
Prevention of Cardiovascular Events
Praluent 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 is indicated:
- To reduce the risk of non-fatal myocardial infarction, ischemic stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
Primary hypercholesterolaemia and mixed dyslipidaemia
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. |
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Product Name
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FORXIGA TABLET 5MG & 10MG
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Active Ingredient
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Dapagliflozin propanediol |
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Product Registrant
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ASTRAZENECA SINGAPORE PTE LTD |
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Date of Approval
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17/10/2019 |
Indications:
Type 2 diabetes mellitus
FORXIGA is indicated in adults with type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise. FORXIGA can be given as monotherapy or in combination with other medicinal products indicated for the treatment of type 2 diabetes mellitus.
For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 5, 6 and 10.
FORXIGA is not indicated for use in patients with type 1 diabetes.
FORXIGA should not be used for the treatment of diabetic ketoacidosis. |
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Product Name
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LYNPARZA FILM COATED TABLETS 100MG, 150MG |
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Active Ingredient
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Olaparib |
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Product Registrant
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ASTRAZENECA SINGAPORE PTE LTD |
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Date of Approval
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23/10/2019 |
Indications:
Lynparza is indicated as monotherapy for the:
• maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. |
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Product Name
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TASIGNA CAPSULE 150MG AND 200MG |
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Active Ingredient
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Nilotinib |
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Product Registrant
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Novartis (Singapore) Pte Ltd |
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Date of Approval
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23/10/2019 |
Indications:
Tasigna hard capsules are indicated for the:
Treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of Tasigna is based on major molecular response and cytogenetic response rates.
Treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant to or intolerant to at least one prior therapy including imatinib. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates.
Treatment of paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals