New drug approvals - Oct 2017

Product Name

GELASPAN SOLUTION FOR INFUSION

Active Ingredient

Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Potassium Chloride, Sodium Acetate Trihydrate, Sodium Chloride, Succinylated Gelatine

Application type

NDA-2: New formulation

Product Registrant

B. BRAUN SINGAPORE PTE. LTD.

Date of Approval

4 Oct 2017

Registration No.

SIN15336P

Indications:

Gelaspan is a colloidal plasma volume substitute in an isotonic, fully balanced electrolyte solution for:

● Prophylaxis and treatment of hypotension caused by relative hypovolaemia during induction of epidural or spinal anaesthesia or due to imminent significant blood loss in a surgical setting

● Procedures involving extracorporeal circulation as a component of priming fluid in combination with crystalloid solutions (e.g. priming of heart-lung machines)

● Acute normovolaemic haemodilution

Product Name

SAXENDA SOLUTION FOR INJECTION IN PRE-FILLED PEN6 MG/ ML

Active Ingredient

Liraglutide

Application type

NDA-2: New indication/ dosing regimen

Product Registrant

NOVO NORDISK PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

9 Oct 2017

Registration No.

SIN15338P

Indications:

Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical

activity for weight management in adult patients with an initial Body Mass Index (BMI) of

· ≥ 30 kg/m² (obese), or

· ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.

Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight.

Product Name

FLUIMUCIL A 600 EFFERVESCENT TABLET 600 MG (OTC PACK)

FLUIMUCIL GRANULES 100 MG/ SACHET (OTC PACK)

Active Ingredient

Acetylcysteine

Application type

NDA-2: New indication

Product Registrant

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

Date of Approval

13 Oct 2017

Registration No.

SIN15339P and SIN15340P

Indications:

FLUIMUCIL^® A 600mg is used as a mucolytic agent in respiratory conditions associated with excessive mucus production.

FLUIMUCIL^® A 100mg is used as a mucolytic agent in respiratory conditions associated with excessive mucus production.

Product Name

BETADINE VAGINAL GEL 10% W/ W

Active Ingredient

Povidone Iodine

Application type

NDA-2: New dosage form

Product Registrant

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

Date of Approval

13 Oct 2017

Registration No.

SIN15344P

Indications:

BETADINE^® Vaginal Gel is specially formulated for vulvar and vaginal antiseptic use.

Product Name

IMPLICOR FILM-COATED TABLET 25 MG/ 5 MG,25 MG/ 7.5 MG, 50 MG/ 5 MG AND 50 MG/ 7.5 MG

Active Ingredient

Metoprolol Tartrate/ Ivabradine

Application type

NDA-2: New combination and NDA-3: New strength

Product Registrant

SERVIER (S) PTE. LTD.

Date of Approval

19 Oct 2017

Registration No.

SIN15347P, SIN15348P, SIN15349P and SIN15350P

Indications:

Implicor is indicated for the symptomatic treatment of chronic stable angina pectoris as substitution therapy in adult patients with normal sinus rhythm already controlled by metoprolol and ivabradine taken concomitantly at the same dose level.

Product Name

EPCLUSA TABLET 400 MG/ 100 MG

Active Ingredient

Sofosbuvir/ Velpatasvir

Application type

NDA-1: New chemical entity

Product Registrant

GILEAD SCIENCES SINGAPORE PTE. LTD.

Date of Approval

19 Oct 2017

Registration No.

SIN15351P

Indications:

Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).

Product Name

NAUSICALM TABLET 50 MG (PHARMACY ONLY)

Active Ingredient

Cyclizine Hydrochloride

Application type

NDA-2: New indication

Product Registrant

AFT PHARMACEUTICALS SINGAPORE PTE. LTD.

Date of Approval

23 Oct 2017

Registration No.

SIN15353P

Indications:

Nausicalm is used to prevent and treat nausea and vomiting associated with motion sickness.