New drug approvals - Apr 2019

Product Name

ALUNBRIG FILM-COATED TABLET 30 MG, ALUNBRIG FILM-COATED TABLET 90 MG, ALUNBRIG FILM-COATED TABLET 180 MG, ALUNBRIG INITIATION PACK FILM-COATED TABLET 90 MG & 180 MG

Active Ingredient

Brigatinib

Application type

NDA-1: New chemical entity

Product Registrant

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Date of Approval

04/04/2019

Registration No.

SIN15658P, SIN15659P, SIN15660P, SIN15661P

Indications: ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

Product Name

LYNPARZA FILM COATED TABLET 100MG, 150MG

Active Ingredient

Olaparib

Application type

NDA-2: New dosage form and NDA-3: New strength

Product Registrant

ASTRAZENECA PTE LTD

Date of Approval

09/04/2019

Registration No.

SIN15662P, SIN15663P

Indications:

Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.

Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA-mutated HER2-negative metastatic breast cancer who have previously been treated with chemotherapy. These patients could have received chemotherapy in the neoadjuvant, adjuvant or metastatic setting.

Product Name

CHOLIB FILM-COATED TABLET 145/20MG

Active Ingredient

Fenofibrate/Simvastatin

Application type

NDA-2: New combination

Product Registrant

ABOTT LABORATORIES PTE LTD

Date of Approval

09/04/2019

Registration No.

SIN15664P

Indications: Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL-C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy. A beneficial effect of Cholib on cardiovascular morbidity and mortality has not yet been demonstrated.

Product Name

PHENYLEPHRINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50MCG/ML

Active Ingredient

Phenylephrine hydrochloride

Application type

NDA-2: New dosage form

Product Registrant

INTEGA PTE LTD

Date of Approval

15/04/2019

Registration No.

SIN15668P

Indications: Treatment of hypotension during general anaesthesia and locoregional anaesthesia, whether spinal or epidural, and whether for surgical or obstetric procedures. Preventive treatment of hypotension during spinal anaesthesia for surgical or obstetric procedures.

Product Name

DAFLON FILM-COATED TABLET 1000 mg

Active Ingredient

Diosmin/Hesperidin

Application type

NDA-3: New strength

Product Registrant

SERVIER (S) PTE LTD

Date of Approval

16/04/2019

Registration No.

SIN15669P

Indications: Treatment of acute hemorrhoidal attacks.

Product Name

TRUXIMA CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/50ML

Active Ingredient

Rituximab

Application type

NDA-2: Biosimilar

Product Registrant

CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

Date of Approval

24/04/2019

Registration No.

SIN15671P

Indications:

Truxima® is indicated for the treatment of patients with relapsed or chemoresistant indolent B-cell non-Hodgkin’s lymphomas.

Truxima® is indicated for the treatment of patients with CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma (DLCL) in combination with CHOP (cyclophosphamide, doxorubicin vincristine and prednisone) chemotherapy.

Truxima® is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with CVP chemotherapy.

Truxima® maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

Chronic Lymphocytic Leukaemia

Truxima® is indicated in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL.

Product Name

BAVENCIO CONCENTRATE FOR SOLUTION FOR INFUSION 200MG/10ML

Active Ingredient

Avelumab

Application type

NDA-1: New chemical entity

Product Registrant

MERCK PTE LTD

Date of Approval

25/04/2019

Registration No.

SIN15672P

Indications: Bavencio is indicated as monotherapy for the treatment of patients with metastatic Merkel cell carcinoma (MCC).

Product Name

DUPIXENT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 300MG / 2ML

Active Ingredient

Dupilimumab

Application type

NDA-1: New chemical entity

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE LTD

Date of Approval

29/04/2019

Registration No.

SIN15675P

Indications: DUPIXENT is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis who require chronic treatment and whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.