New drug approvals - May 2020

Product Name

AJOVY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 225MG/1.5ML

Active Ingredient

FREMANEZUMAB

Application type

NDA-1: New biological entity

Product Registrant

DRUG HOUSES OF AUSTRALIA PTE LTD

Date of Approval

08 MAY 2020

Registration No.

SIN15937P

Indications:

Ajovy is indicated for the preventive treatment of migraine in adults

Product Name

TUKYSA FILM-COATED TABLETS 50 MG AND 150 MG

Active Ingredient

Tucatinib

Application type

NDA-1: New chemical entity

Product Registrant

NYPRAX PHARMA PTE. LTD.

Date of Approval

19/05/2020

Registration No.

SIN15942P, SIN15943P

Indications:

TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

*Evaluated as part of Project Orbis

Product Name

TALZENNA CAPSULE 0.25MG AND 1MG

Active Ingredient

Talazoparib tosylate

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

22/05/2020

Registration No.

SIN15944P, SIN15945P

Indications:

TALZENNA is indicated for the treatment of adult patients with germline breast cancer susceptibility gene (BRCA) mutated human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer who have previously been treated with chemotherapy. These patients could have received chemotherapy in the neoadjuvant, adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments.