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New drug approvals - July 2023

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

Product Name	RHOPRESSA OPHTHALMIC SOLUTION, STERILE 0.02%
Active Ingredient	Netarsudil mesylate
Application type	NDA-1: New chemical entity
Product Registrant	SANTEN PHARMACEUTICAL ASIA PTE LTD
Date of Approval	4/7/2023
Registration No.	SIN16816P
Indications: RHOPRESSA (netarsudil ophthalmic solution) 0.02% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. (See section 12 Clinical Studies).

Product Name	ROCKLATAN OPHTHALMIC SOLUTION, STERILE 0.02%/0.005%
Active Ingredient	Netarsudil mesylate/Latanoprost
Application type	NDA-2: New combination
Product Registrant	SANTEN PHARMACEUTICAL ASIA PTE LTD
Date of Approval	4/7/2023
Registration No.	SIN16818P
Indications: ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin F2α analogue or rho kinase inhibitor provides insufficient IOP reduction.

Product Name	TEZSPIRE SOLUTION FOR INJECTION 210MG (PRE-FILLED SYRINGE)
Active Ingredient	Tezepelumab
Application type	NDA-1: New chemical entity
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	4/7/2023
Registration No.	SIN16815P
Indications: TEZSPIRE is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite medium or high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Product Name	TEZSPIRE SOLUTION FOR INJECTION 210MG (PRE-FILLED PEN)
Active Ingredient	Tezepelumab
Application type	NDA-2: New presentation
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	4/7/2023
Registration No.	SIN16817P
Indications: TEZSPIRE is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite medium or high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Product Name	BRAFTOVI HARD CAPSULE 50 MG AND 75 MG
Active Ingredient	Encorafenib
Application type	NDA-1/3: New chemical entity and strength
Product Registrant	ZUELLIG PHARMA PTE. LTD.
Date of Approval	19/7/2023
Registration No.	SIN16824P and SIN16825P
Indications: Melanoma Encorafenib, in combination with binimetinib, is indicated for the treatment of adult patients who have unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by a validated test. Colorectal Cancer Encorafenib, in combination with cetuximab, is indicated for the treatment of adult patients who have metastatic colorectal cancer (mCRC) with a BRAF V600E mutation as detected by a validated test, and who have received prior systemic therapy.

Product Name	MEKTOVI FILM-COATED TABLET 15MG
Active Ingredient	Binimetinib
Application type	NDA-1: New chemical entity
Product Registrant	ZUELLIG PHARMA PTE. LTD.
Date of Approval	19/7/2023
Registration No.	SIN16826P
Indications: Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by a validated test.

Product Name	VITRAKVI ORAL SOLUTION 20MG/ML
Active Ingredient	Larotrectinib sulfate eqv Larotrectinib
Application type	NDA-2: New formulation
Product Registrant	Bayer (South East Asia) Pte Ltd
Date of Approval	28/7/2023
Registration No.	SIN16827P
Indications: VITRAKVI as monotherapy is indicated for the treatment of adult and pediatric patients with solid tumors · that display a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, · who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and · who have no satisfactory treatment options

Healthcare professional, Industry member, Therapeutic Products

Published: 31 Jul 2023

New Drug Approvals