New drug approvals - Oct 2016

 

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.

 

Product Name

DENGVAXIA, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Active Ingredient

CYD Dengue Virus Serotypes 1, 2, 3 and 4

Application type

NDA-1: New biological entity

Licence Holder

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

11 Oct 2016

Licence No.

SIN15096P

Indications:

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).

 

Product Name

DENGVAXIA MD, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Active Ingredient

CYD Dengue Virus Serotypes 1, 2, 3 and 4

Application type

NDA-2: New formulation (multi-dose)

Licence Holder

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

11 Oct 2016

Licence No.

SIN15097P

Indications:

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).

 

Product Name

NEUROBION TABLET (OTC)

Active Ingredient

Cyanocobalamin, Pyridoxine Hydrochloride and Thiamine Disulphide

Application type

NDA-2: New indication

Licence Holder

MERCK PTE. LTD.

Date of Approval

13 Oct 2016

Licence No.

SIN15098P

Indications:

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.

 

Product Name

TRIUMEQ FILM COATED TABLET 50 MG/ 600 MG/ 300 MG

Active Ingredient

Dolutegravir/ Abacavir/ Lamivudine

Application type

NDA-2: New combination

Licence Holder

GLAXOSMITHKLINE PTE. LTD.

Date of Approval

14 Oct 2016

Licence No.

SIN15100P

Indications:

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.

 

Product Name

BLINCYTO POWDER FOR INFUSION 35 MCG/ VIAL

Active Ingredient

Blinatumomab

Application type

NDA-1: New biological entity

Licence Holder

ADOR CONSULTING PTE. LTD.

Date of Approval

18 Oct 2016

Licence No.

SIN15103P

Indications:

Blincyto is indicated for the treatment of adults with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

 

Product Name

DARZALEX CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/ 5 ML AND 400 MG/ 20 ML

Active Ingredient

Daratumumab

Application type

NDA-1: New biological entity and NDA-3: New strength

Licence Holder

JOHNSON & JOHNSON PTE. LTD.

Date of Approval

26 Oct 2016

Licence No.

SIN15110P, SIN15111P

Indications:

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.

 

Healthcare professional, Therapeutic Products
Published:

New Drug Approvals