New drug approvals - Feb 2020

Product Name

SPIRIVA RESPIMAT RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM

Active Ingredient

Tiotropium

Application type

NDA-2: New presentation

Product Registrant

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Date of Approval

18/02/2020

Registration No.

SIN15885P

Indications:

COPD

Spiriva Respimat re-usable is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).

Asthma

Spiriva Respimat re-usable is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with moderate to severe asthma.

Product Name

GLANATEC OPHTHALMIC SOLUTION 0.4% W/V

Active Ingredient

Ripasudil Hydrochloride Hydrate

Application Type

NDA-1: New chemical entity

Product Registration

DKSH Singapore Ptd Ltd

Date of Approval

18/02/2020

Registration No.

SIN15886P

Indications:

Glanatec is indicated to decrease elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma as adjunctive therapy in patients who are insufficiently responsive to topical beta-blockers or prostaglandin analogues, or as monotherapy in patients who are intolerant or contraindicated to other intraocular pressure lowering medications.

Product Nam

BOOSTRIX POLIO SUSPENSION FOR INJECTION

Active Ingredients

TETANUS TOXOID(20 iu/0.5 ml),DIPHTHERIA TOXOID(2 iu/0.5 ml),PERTACTIN(2.5 mcg/0.5 ml), FILAMENTOUS HAEMAGGLUTININ(8 mcg/0.5 ml),PERTUSSIS TOXOID(8mcg/0.5ml)

Application type

NDA-2

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

20/02/2020

Registration No.

SIN15888P

Indications:
Boostrix Polio is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of three years onwards.

Product Name

SPIOLTO RESPIMAT RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM / 2.5 MICROGRAM

Active Ingredients

Tiotropium / Olodaterol

Application type

NDA-2: New presentation

Product Registrant

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Date of Approval

25/01/2020

Registration No.

SIN15890P

Indications:Spiolto Respimat re-usable is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Product Name

ENSTILAR CUTANEOUS FORM

Active Ingredient

Betamethasone dipropionate 0.5mg/g and Calcipotriol 50mcg/g

Application Type

NDA-2: New presentation

Product Registration

Leo Pharma AsiaPtd Ltd

Date of Approval

27/02/2020

Registration No.

SIN15892P

Indications:Topical treatment of psoriasis vulgaris in adults

Product Name

VYNDAQEL SOFT GELATIN CAPSULE 20 MG,VYNDAMAX SOFT GELATIN CAPSULE 61 MG

Active Ingredient

Tafamidis meglumine (for Vyndaqel),Tafamidis (for Vyndamax)

Application Type

NDA-1: New chemical entity, NDA-2: New dosage form

Product Registration

Pfizer Private Limited

Date of Approval

27/02/2020

Registration No.

SIN15893P. SIN15894P

Indications: VYNDAQEL/VYNDAMAX is indicated for the treatment of transthyretin amyloidosis in adult patients with wild-type or hereditary cardiomyopathy to reduce all-cause mortality and cardiovascular-related hospitalisation.

*Evaluated via Access

Product Name

HAEMOCOMPLETTAN P POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G/VIAL

Active Ingredient

Human Fibrinogen

Application Type

NDA-1: New chemical entity, NDA-2: New dosage form

Product Registration

CSL Behring Pte Ltd

Date of Approval

28/02/2020

Registration No.

SIN15895P

Indications:

Therapy and prophylaxis of haemorrhagic diatheses in:

• Congenital hypo- or afibrinogenaemia