New drug indication approval - September 2021

Product Name

COSENTYX POWDER FOR SOLUTION FOR INJECTION 150MG/VIAL

COSENTX SOLUTION FOR INJECTION IN PREFILLED SENSOREADY PEN 150MG/ML

COSENTYX SOLUTION FOR INJECTION IN PREFILLED SYRINGE 150MG/ML

Active Ingredient

Secukinumab

Product Registrant

Novartis (Singapore) Pte Ltd

Date of Approval

1/9/2021

Indications:

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adult patients 6 years and older who are candidates for systemic therapy or phototherapy (See section Clinical Studies)

Product Name

PAMORELIN POWDER FOR SUSPENSION FOR INJECTION 3.75 MG PER VIAL

Active Ingredient

Triptorelin Embonate eqv. Triptorelin

Product Registrant

ORIENT EUROPHARMA PTE LTD

Date of Approval

06/09/2021

Indications:

Pamorelin 3.75 mg is indicated as adjuvant treatment, in combination with tamoxifen or an aromatase inhibitor, of hormone receptor positive early stage breast cancer in women at high risk of recurrence who are confirmed as premenopausal after completion of chemotherapy.

Product Name

CABOMETYX FILM COATED TABLETS 20MG, 40MG, 60MG

Active Ingredient

Cabozantinib

Product Registrant

IPSEN PHARMA PTE LTD

Date of Approval

06/09/2021

Indications:

CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).

Product Name

ERAXIS 100MG FOR INJECTION

Active Ingredient

Anidulafungin

Product Registrant

PFIZER PTE LTD

Date of Approval

22/09/2021

Indications:

Treatment of invasive candidiasis in adult and in paediatric patients one month and older.

Product Name

VIGAMOX OPHTHALMIC SOLUTION 0.5%

Active Ingredient

Moxifloxacin

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

22/09/2021

Indications:

VIGAMOX solution is indicated for the treatment of bacterial conjunctivitis, blepharitis, dacryocystitis, hordeolum, tarsadenitis, keratitis (including corneal ulcer) caused by susceptible strains, as well as preoperative and postoperative prophylaxis.

Product Name

OPDIVO (NIVOLUMAB) CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML

Active Ingredient

Nivolumab

Product Registrant

Bristol Myers Squibb

Date of Approval

20/10/2021

Indications:

Malignant pleural mesothelioma (MPM)

OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

Renal Cell Carcinoma (RCC)

OPDIVO in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (see section 5.1).