New drug indication approval - January 2022

Product Name

KEYTRUDA SOLUTION FOR INFUSION 25MG/ML

Active Ingredient

Pembrolizumab

Product Registrant

MSD PHARMA (SINGAPORE) PTE. LTD

Date of Approval

04/01/2022

Indications:

KEYTRUDA is indicated for the first-line treatment of patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).

KEYTRUDA is indicated for the treatment of adult and pediatric patients aged 3 years and above, with relapsed or refractory classical Hodgkin lymphoma (cHL), who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumours express PDL1 (CPS ≥10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease (see clinical studies).

*Evaluated as part of Project Orbis

Product Name

SYMVENU HARD CAPSULES 1.5MG, 3MG, 4.5MG, 6MG

Active Ingredient

Cariprazine hydrochloride eqv cariprazine

Product Registrant

MITSUBISHI TANABE PHARMA SINGAPORE PTE LTD

Date of Approval

25/01/2022

Indications:

Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult patients

Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients.

Product Name

ZAVICEFTA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 2G/0.5G

Active Ingredient

Ceftazidime pentahydrate, avibactam sodium

Product Registrant

Pfizer Private Limited

Date of Approval

26/01/2022

Indications:

Zavicefta is indicated in adults, infants (aged 3 months and older), children, and adolescents for the treatment of the following infections (see sections 4.4 and 5.1):

• Complicated Intra-Abdominal Infection (cIAI)

• Complicated Urinary Tract Infection (cUTI), including Pyelonephritis

• Hospital-acquired Pneumonia (HAP), including ventilator associated pneumonia (VAP)

Treatment of adult patients with bacteraemia that occurs in association with, or is suspected to be associated with cIAI, cUTI, or HAP/VAP.

Consideration should be given to official guidance on the appropriate use of antibacterial agents. For treatment of cIAI use in combination with metronidazole.

Product Name

XYNTHA POWDER AND SOLVENT FOR SOLUTION

FOR INJECTION 250IU/ 500IU/ 1000IU/ 2000IU

Active Ingredient

Moroctocog alfa (AF-CC)

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

28/1/2022

Indications:

Routine and Surgical Prophylaxis in Patients with Hemophilia A

XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for routine and surgical prophylaxis in patients with hemophilia A.

XYNTHA is appropriate for use in children of all ages, including newborns.

XYNTHA does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand's disease

Product Name

DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 200 mg/1.14ml / 300mg/2ml

Active Ingredient

Dupilumab

Product Registrant

Sanofi-Aventis Singapore Pte. Ltd.

Date of Approval

28/1/2022

Indications:

Atopic Dermatitis

DUPIXENT is indicated for the treatment of patients aged 6 years and older 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.