New Drug Indication Approval – June 2023

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Product NameDUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 300MG/2ML
Active IngredientDupilumab
Product RegistrantSANOFI-AVENTIS SINGAPORE PTE LTD
Date of Approval04/06/2023
Indications:

1.4 Prurigo Nodularis

DUPIXENT is indicated for the treatment of adult patients with moderate-to-severe prurigo nodularis (PN) 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.
Product NameIDACIO SOLUTION FOR INJECTION IN PRE-FILLED PEN 40MG/0.8MLIDACIO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 40MG/0.8MLIDACIO SOLUTION FOR INJECTION FOR PAEDIATRIC USE 40MG/0.8ML VIAL
Active IngredientAcdalimumab
Product RegistrantFRESENIUS KABI (SINGAPORE) PTE LTD
Date of Approval13/06/2023
Indications:

Pediatric Ulcerative Colitis

IDACIO is indicated for inducing and maintaining clinical remission in pediatric patients 5 years of age or older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Product NameAMGEVITA SOLUTION FOR INJECTION IN PREFILLED SYRINGE 20MG/0.4ML AND 40MG/0.8MLAMGEVITA SOLUTION FOR INJECTION IN PREFILLED AUTOINJECTOR 40MG/0.8ML
Active IngredientAdalimumab
Product RegistrantAMGEN BIOTECHNOLOGY SINGAPORE PTE LTD
Date of Approval05/06/2023
Indications:

Pediatric Ulcerative Colitis

AMGEVITA is indicated for inducing and maintaining clinical remission in pediatric patients 5 years of age or older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Product NameABRILADA SOLUTION FOR INJECTION IN SINGLE-DOSE PREFILLED SYRINGE 20 MG/0.4 MLABRILADA SOLUTION FOR INJECTION IN SINGLE-DOSE PREFILLED PEN 40 MG/0.8 MLABRILADA SOLUTION FOR INJECTION IN SINGLE-DOSE PREFILLED SYRINGE 40 MG/0.8 ML
Active IngredientAdalimumab
Product RegistrantPFIZER PRIVATE LIMITED
Date of Approval16/06/2023
Indications:

Paediatric ulcerative colitis

ABRILADA is indicated for inducing and maintaining clinical remission in paediatric patients 5 years of age or older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Product NameSCEMBLIX FILM-COATED TABLET 20 MGSCEMBLIX FILM-COATED TABLET 40 MG
Active IngredientAsciminib hydrochloride
Product RegistrantNOVARTIS (SINGAPORE) PTE LTD
Date of Approval22/06/2023
Indications:

Adult patients with philadelphia chromosomeโ€“positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), harboring the T315I mutation.

Link to the original news (HSA) :

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

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