New Drug Indication Approval – July 2023

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Product NameKEYTRUDA SOLUTION FOR INFUSION 25MG/ML
Active IngredientPembrolizumab
Product RegistrantMSD PHARMA (SINGAPORE) PTE. LTD.
Date of Approval14/07/2023
Indications:

KEYTRUDA, as monotherapy, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adults patients with Stage IB (T2a โ‰ฅ4 cm), II, or IIIA NSCLC (Non-small cell lung cancer).
Product NameOPDIVO 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION.
Active IngredientNivolumab.
Product RegistrantBRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
Date of Approval19/07/2023
Indications:

OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression โ‰ฅ1%.

OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression โ‰ฅ1%.
Product NameDUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 300 MG/2 MLDUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 200 MG/1.14 ML
Active IngredientDupilumab
Product RegistrantSANOFI-AVENTIS SINGAPORE PTE LTD
Date of Approval26/07/2023
Indications:

DUPIXENT is indicated for the treatment of adults and pediatric patients aged 6 months 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.

Link to the original news (HSA) :

https://www.hsa.gov.sg/announcements/new-drug-indication-approvals/new-drug-indication-approval—july-2023

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