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New drug approvals - August 2023

Please click here for a list of summary reports of benefit-risk assessments.

Product Name	NAGLAZYME CONCENTRATE FOR SOLUTION FOR INFUSION
Active Ingredient	Galsulfase
Application type	NDA-1: New biological entity
Product Registrant	PHARM-D SINGAPORE PRIVATE LIMITED
Date of Approval	11/08/2023
Registration No.	SIN16831P
Indications: NAGLAZYME is indicated for long-term enzyme replacement therapy in patients with Mucopolysaccharidosis VI (MPS VI, N-acetylgalactosamine 4-sulfatase deficiency, Maroteaux-Lamy syndrome).

Product Name	ABILIFY MAINTENA POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION IN PFS 400 MG
Active Ingredient	Aripiprazole
Application type	NDA-2: New dosage form
Product Registrant	LUNDBECK SINGAPORE PTE LTD
Date of Approval	14/08/2023
Registration No.	SIN16832P
Indications: - For the acute and maintenance treatment of schizophrenia in adults - For maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy

Product Name	ABILIFY MAINTENA POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION IN PFS 400 MG
Active Ingredient	Aripiprazole
Application type	NDA-2: New dosage form
Product Registrant	LUNDBECK SINGAPORE PTE LTD
Date of Approval	14/08/2023
Registration No.	SIN16832P
Indications: - For the acute and maintenance treatment of schizophrenia in adults - For maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy

Product Name	SPIKEVAX 0.2 mg/mL DISPERSION FOR INJECTION
Active Ingredient	Elasomeran
Application type	NDA-1: New biological entity (Transition from PSAR to marketing authorisation)
Product Registrant	MODERNA BIOTECH SINGAPORE PTE. LTD.
Date of Approval	17/08/2023
Registration No.	SIN16834P
Indications: Spikevax is indicated for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 6 years of age and older. The use of this vaccine should be in accordance with official recommendations.

Product Name	SPIKEVAX 0.1 mg/mL DISPERSION FOR INJECTION
Active Ingredient	Elasomeran
Application type	NDA-2: New strength (Transition from PSAR to marketing authorisation)
Product Registrant	MODERNA BIOTECH SINGAPORE PTE. LTD.
Date of Approval	17/08/2023
Registration No.	SIN16835P
Indications: Spikevax is indicated for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.

Product Name	GALLIAPHARM RADIONUCLIDE GENERATOR 0.74 – 1.85 GBq
Active Ingredient	Germanium (68Ge) chloride; Gallium (68Ga) chloride
Application type	NDA-1: New chemical entity
Product Registrant	LABGISTICS ASIA PTE LTD
Date of Approval	23/08/2023
Registration No.	SIN16844P
Indications: This pharmaceutical product is not intended for direct use in patients. The eluate from the radionuclide generator (gallium (68Ga) chloride solution) is indicated for in vitro labelling of specific carrier molecules developed and approved for radiolabelling with such solution to be used for positron emission tomography (PET) imaging.

Product Name	IMJUDO CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML
Active Ingredient	Tremelimumab
Application type	NDA-1: New biological entity
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	25/08/2023
Registration No.	SIN16845P
Indications: IMJUDO in combination with durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior systemic therapy.

Product Name	SELENIUM AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 10 MCG/ML
Active Ingredient	Sodium Selenite
Application type	NDA-2: New presentation
Product Registrant	AGUETTANT ASIA PACIFIC PTE. LTD.
Date of Approval	27/08/2023
Registration No.	SIN16847P
Indications: Selenium supplementation during parenteral nutrition. Treatment of proven selenium deficiency that cannot be compensated by nutrition alone

Product Name	OPDUALAG CONCENTRATE FOR SOLUTION FOR INFUSION 240MG/80MG
Active Ingredient	Nivolumab/relatlimab
Application type	NDA-1: New biological entity
Product Registrant	BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
Date of Approval	31/08/2023
Registration No.	SIN16852P
Indications: Opdualag is indicated for the first-line treatment of unresectable or metastatic melanoma in adults with tumour cell PD-L1 expression < 1%. *Evaluated as part of Project Orbis

Healthcare professional, Industry member, Therapeutic Products

Published: 31 Aug 2023

New Drug Approvals