New drug approvals - May 2022

Product Name

XARELTO GRANULES FOR ORAL SUSPENSION 1MG/ML

Active Ingredient

Rivaroxaban

Application type

NDA-2: New dosage form

Product Registrant

BAYER (SOUTH EAST ASIA) PTE LTD

Date of Approval

06 May 2022

Registration No.

SIN16487P

Indications:

Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in term neonates, infants and toddlers, children, and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment.

Product Name

NOXBETA TABLET 5 MG

Active Ingredient

Nebivolol (as nebivolol hydrochloride)

Application type

NDA-2: New brand

Product Registrant

A. MENARINI SINGAPORE PTE. LTD.

Date of Approval

06 May 2022

Registration No.

SIN16486P

Indications:

Hypertension

Treatment of essential hypertension.

Chronic heart failure (CHF)

Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients > 70 years.

Product Name

PARMODIA FILM-COATED TABLETS 0.1 MG

Active Ingredient

Pemafibrate

Application type

NDA-1

Product Registrant

DKSH SINGAPORE PTE. LTD.

Date of Approval

18 May 2022

Registration No.

SIN16492P

Indications:

PARMODIA is indicated as adjunctive therapy to diet or other nonpharmacological treatment (e.g. exercise) to reduce TG and to increase HDL-C in patients with dyslipidemia characterised by high TG ≥150 mg/dL, particularly when there is evidence of associated risk such as hypertension and smoking.

Product Name

PADCEV POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 20MG AND 30MG

Active Ingredient

Enfortumab vedotin

Application type

NDA-1

Product Registrant

ASTELLAS PHARMA SINGAPORE PTE. LTD.

Date of Approval

30 May 2022

Registration No.

SIN16502P, SIN16503P

Indications:

Padcev is indicated for the treatment of adult patients with locally advanced (LA) or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

Product Name

TIVICAY DISPERISBLE TABLET 5MG

Active Ingredient

Dolutegravir

Application type

NDA-2

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

30 May 2022

Registration No.

SIN16504P

Indications:

Treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in adults and children aged at least 4 weeks of age or older and weighing at least 3 kg.

Product Name

BOOSTAGEN SUSPENSION FOR INJECTION

Active Ingredient

Diphtheria Toxoid (DT)(2.0 Lf / 0.5ml), Filamentous Haemagglutinin (FHA)(5ug/0.5ml), Recombinant Pertussis Toxin (rPT)(5ug/0.5ml), Tetanus Toxoid (TT)(7.5 Lf/0.5ml)

Application type

NDA-1

Product Registrant

NOVEM HEALTHCARE PTE LTD

Date of Approval

18/05/2022

Registration No.

SIN16493P

Indications:

Boostagen® is indicated for active booster immunization against tetanus, diphtheria and pertussis in individuals from the age of 11 years onwards.

Boostagen® should be given in accordance with the current local recommendations and medical practices for booster vaccination against diphtheria, tetanus and pertussis.