New Drug Indication Approval – May 2023

This content is first seen at HSA
Disclaimer: The information provided in this site is correct at the time of publication. POMConnect assumes no responsibility or liability for any errors or omissions in the content of this site.

Product NameREXULTI FILM COATED TABLETS 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG
Active IngredientBrexpiprazole
Product RegistrantLUNDBECK SINGAPORE PTE LTD
Date of Approval02/05/2023
Indications: Treatment of schizophrenia (see section 5.1) in adults and pediatric patients aged 13 years and older.
Product NameRINVOQ EXTENDED-RELEASE TABLET 15MG, 30MG, 45MG
Active IngredientUpadacitinib Hemihydrate eqv Upadacitinib
Product RegistrantABBVIE PTE. LTD.
Date of Approval11/05/2023
Indications: RINVOQ is indicated for the treatment of adults 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).RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Product NameKEYTRUDA SOLUTION FOR INFUSION 25 MG/ML
Active IngredientPembrolizumab
Product RegistrantMSD PHARMA (SINGAPORE) PTE. LTD.
Date of Approval17/05/2023
Indications:
Melanoma
KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC or III melanoma who have undergone complete resection.

Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with an anti-angiogenic tyrosine kinase inhibitor (TKI).

Renal Cell Carcinoma
KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of patients with advanced RCC.

Endometrial Carcinoma
KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Product NameFORXIGA TABLET 5MG, 10MG
Active IngredientDapagliflozin propanediol
Product RegistrantASTRAZENECA SINGAPORE PTE LTD
Date of Approval26/05/2023
Indications:FORXIGA is indicated in adults with heart failure (NYHA class II-IV) to reduce the risk of cardiovascular death and hospitalization for heart failure (see section 5.1).

Link to the original news (HSA) :

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

POMConnect Banner2 Email Bottom

Copyright ยฉ 2025 DocMed Technology Pte Ltd. All rights reserved.