New drug approvals - Mar 2016

 

Product Name

GANFORT PF EYE DROPS

Active Ingredient

Bimatoprost, Timolol

Application type

NDA-2: New formulation

Licence Holder

ALLERGAN SINGAPORE PTE. LTD.

Date of Approval

11 Mar 2016

Licence No.

SIN14966P

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.

 

Product Name

TRULICITY INJECTION 0.75 MG/0.5 ML AND 1.5 MG/0.5 ML

Active Ingredient

Dulaglutide

Application type

NDA-1: New chemical entity

NDA-3: New strength

Licence Holder

ELI LILLY (SINGAPORE) PTE LTD

Date of Approval

18 Mar 2016

Licence No.

SIN14967P, SIN14968P

Indications:

Trulicity is indicated in adults with type 2 diabetes mellitus to improve glycaemic control as:

Monotherapy

When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.

Add-on therapy

In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 for data with respect to different combinations).

 

Product Name

REMSIMA® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/VIAL

Active Ingredient

Infliximab

Application type

NDA-2: Biosimilar

Licence Holder

CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

Date of Approval

28 Mar 2016

Licence No.

SIN14972P

Indications:

Rheumatoid arthritis:

Remsima, in combination with methotrexate, is indicated for:

The reduction of signs and symptoms as well as the improvement in physical function in

-patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate.

-patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.

In these patient populations, a reduction in the rate of the progression of joint damage, as measured by x-ray, has been demonstrated (see section 5.1).

Ankylosing spondylitis

Remsimais indicated for:

Treatment of ankylosingspondylitis, in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.

 

Psoriatic arthritis

Remsima, in combination with methotrexate, is indicated for:

Treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease-modifying anti-rheumatoid drugs.

 

Psoriasis

Remsimais indicated for:

Treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultraviolet A (PUVA)(see section 5.1).

 

Healthcare professional, Therapeutic Products
Published:

New Drug Approvals