New drug indication approval - Feb 2021

Product Name

ZINFORO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 600MG/VIAL

Active Ingredient

Ceftaroline

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

04/02/2021

Indications:

Zinforo is indicated for the treatment of the following infections caused by susceptible isolates of the designated microorganisms:

  • Complicated skin and soft tissue infections (cSSTI)

  • Community-acquired pneumonia (CAP)

Zinforo is indicated in neonates, infants, children, adolescents and adults.

Product Name

ZOLADEX LA DEPOT INJECTION 10.8 MG/SYRINGE

Active Ingredient

Goserelin

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

16/02/2021

Indications:

ZOLADEX LA 10.8mg is indicated in the management of estrogen-receptor-positive breast cancer in premenopausal women.

Product Name

TALTZ SOLUTION FOR INJECTION IN PRE-FILLED PEN 80 MG/ML

Active Ingredient

Ixekizumab

Product Registrant

DKSH SINGAPORE PTE. LTD.

Date of Approval

24/02/2021

Indications:

Axial spondyloarthritis

Ankylosing spondylitis (radiographic axial spondyloarthritis)

Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.

Non-radiographic axial spondyloarthritis

Taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

 

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Indication Approvals