Product Name
BYDUREON POWDER AND SOLVENT FOR PROLONGED- RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED PEN 2 MG
Active Ingredient
Exenatide
Application type
NDA-2: New dosage form/ dosing regimen
Licence Holder
ASTRAZENECA SINGAPORE PTE. LTD.
Date of Approval
10 Oct 2016
Licence No.
SIN15095P
Indications:
Bydureon is indicated for treatment of type 2 diabetes mellitus in combination with
· Metformin
· Sulphonylurea
· Metformin and sulphonylurea
in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
DENGVAXIA, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
CYD Dengue Virus Serotypes 1, 2, 3 and 4
NDA-1: New biological entity
SANOFI-AVENTIS SINGAPORE PTE. LTD.
11 Oct 2016
SIN15096P
Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 12 through 45 years of age living in endemic areas (see Section 4.2).
DENGVAXIA MD, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
NDA-2: New formulation (multi-dose)
SIN15097P
Dengvaxia MD is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 12 through 45 years of age living in endemic areas (see Section 4.2).
NEUROBION TABLET (OTC)
Cyanocobalamin, Pyridoxine Hydrochloride and Thiamine Disulphide
NDA-2: New indication
MERCK PTE. LTD.
13 Oct 2016
SIN15098P
It is indicated for nerve pain expressed in one or more of the following symptoms: pricking/ tingling sensation, numbness, muscle stiffness, muscle cramp, impaired sensation.
TRIUMEQ FILM COATED TABLET 50 MG/ 600 MG/ 300 MG
Dolutegravir/ Abacavir/ Lamivudine
NDA-2: New combination
GLAXOSMITHKLINE PTE. LTD.
14 Oct 2016
SIN15100P
TRIUMEQ is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents from 12 years of age and weighing at least 40kg, who are antiretroviral treatment-naïve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents in TRIUMEQ.
BLINCYTO POWDER FOR INFUSION 35 MCG/ VIAL
Blinatumomab
ADOR CONSULTING PTE. LTD.
18 Oct 2016
SIN15103P
Blincyto is indicated for the treatment of adults with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
DARZALEX CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/ 5 ML AND 400 MG/ 20 ML
Daratumumab
NDA-1: New biological entity and NDA-3: New strength
JOHNSON & JOHNSON PTE. LTD.
26 Oct 2016
SIN15110P, SIN15111P
DARZALEX™ is indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
New Drug Approvals