NEW INDICATION APPROVALS

XTANDI SOFT CAPSULES 40MG Active Ingredient: Enzalutamide Licence Holder: Astellas Pharma Singapore Pte. Ltd. Date of Approval: 5 April 2016 Indications: Xtandi is indicated for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated […]

NEW HSA Drug Approvals Source: HSA (http://www.hsa.gov.sg, April – May 2016)

OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML Active Ingredient: Nivolumab Licence Holder: Bristol-Myers Squibb (Singapore) Pte. Ltd. Date of Approval: 4 April 2016 Indications: Melanoma OPDIVO as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Non-Small Cell Lung Cancer (NSCLC) OPDIVO as monotherapy is indicated for the treatment of […]

NEW HSA Drug Approvals Source: HSA (http://www.hsa.gov.sg, March 2016)

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GANFORT PF EYE DROPS Active Ingredient: Bimatoprost, Timolol Licence Holder: Allergan Singapore Pte Ltd Date of Approval: 11 March 2016 Indications: GANFORT® PF eye drops are indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. TRULICITY INJECTION 0.75 […]

New HSA Drug Approvals

Source: HSA (http://www.hsa.gov.sg, January-February 2015) ARTISS SOLUTION FOR SEALANT, DEEP FROZEN Active Ingredients: Aprotinin (synthetic), human thrombin, calcium chloride, human fibrinogen Licence Holder: Baxter Healthcare (Asia) Pte. Ltd. Date of Approval: 6 January 2015 Indications: ARTISS is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and paediatric […]

USA: Rani Therapeutics (TM) Announces Collaboration with Novartis

In late May, Rani Therapeutics announced that it had entered into a collaboration with Novartis to evaluate Rani’s novel oral biotherapeutics drug delivery platform. The companies have agreed to begin feasibility studies to evaluate how selected Novartis’ proprietary biologics can be delivered into the bloodstream using Rani’s unique route of administration. After successful completion of […]

New HSA Drug Approvals

New HSA Drug Approvals Source: HSA (http://www.hsa.gov.sg, December 2014)   AUGMENTIN SR TABLET 1000/62.5MG Active Ingredient: Amoxicillin trihydrate, amoxicillin sodium, potassium clavulanate Licence Holder: Glaxosmithkline Pte. Ltd. Date of Approval: 3 December 2014  Indications:  AUGMENTIN should be used in accordance with local official antibiotic prescribing guidelines and local susceptibility data. AUGMENTIN SR is indicated for […]

VIMPAT FILM-COATED TABLET 50MG

Active Ingredient: Lacosamide Licence Holder: A. Menarini Singapore Pte. Ltd. Date of Approval: 18 November 2014 Indications: Vimpat is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.

LYXUMIA SOLUTION FOR INJECTION IN PRE-FILLED PEN 10MCG, 20MCG, 10MCG & 20MCG STARTER PACK

Active Ingredient: Lixisenatide Licence Holder: Sanofi-Aventis Singapore Pte. Ltd. Date of Approval: 30 October 2014 Indications: Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with metformin, sulphonylurea, or a basal insulin, metformin and sulphonylurea, and basal insulin and metformin when these, together with diet […]

ZUTECTRA SOLUTION FOR INJECTION 500IU/ML

Active Ingredient: Human hepatitis B immunoglobulin in 150g/l human plasma protein (IgG ≥ 96%) Licence Holder: Eshcol Pharmaceutical Group Singapore Pte. Ltd. Date of Approval: 24 October 2014  Indications: Prevention of hepatitis B virus (HBV) re-infection in HBV-DNA negative patients ≥ six months after liver transplantation for hepatitis B induced liver failure. Zutectra is indicated […]

MAXIGESIC TABLET 500MG/150MG

Active Ingredient: Paracetamol/Ibuprofen Licence Holder: DKSH Singapore Pte. Ltd. Date of Approval: 23 October 2014  Indications: Maxigesic® tablets are indicated for temporary relief of mild to moderate pain associated with headache, dental pain, period pain, migraine, backache, rheumatic pain, muscular pain, pain after vaccination and sore throat, and reduction of fever. This product is especially suitable […]

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