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New drug approvals - September 2022

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

Product Name	DUCRESSA EYE DROPS SOLUTION 1MG/ML + 5MG/ML
Active Ingredient	Dexamethasone sodium phosphate 1.32mg/mL (eqv to Dexamethasone 1.00mg/mL) Levofloxacin hemihydrate 5.12mg/mL (eqv to Levofloxacin 5.00mg/Ml)
Application type	NDA-2: New combination
Product Registrant	SANTEN PHARMACEUTICAL ASIA PTE LTD
Date of Approval	07/09/2022
Registration No.	SIN16596P
Indications: Ducressa eye drops solution is indicated for prevention and treatment of inflammation, and prevention of infection associated with cataract surgery in adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Product Name	BLENREP POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG
Active Ingredient	Belantamab mafodotin
Application type	NDA-1
Product Registrant	GLAXOSMITHKLINE PTE LTD
Date of Approval	21/09/2022
Registration No.	SIN16606P
Indications: BLENREP is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least 4 prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Product Name	JINARC TABLET 15MG, 30MG, 45MG/15MG, 60MG/30MG, 90MG/30MG
Active Ingredient	Tolvaptan
Application type	NDA-2/3: New indication/strength/dosing regimen
Product Registrant	Otsuka Pharmaceuticals (Singapore) Pte. Ltd.
Date of Approval	23 Sep 22
Registration No.	SIN16607P, SIN16608P, SIN16609P, SIN16610P, SIN16611P
Indications: JINARC is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) at initiation of treatment with evidence of rapidly progressing disease (see section 4.2 and 5.1).

Product Name	STAQUIS OINTMENT 2% W/W
Active Ingredient	Crisaborole
Application type	NDA-1: New chemical entity
Product Registrant	PFIZER PRIVATE LIMITED
Date of Approval	27/09/2022
Registration No.	SIN16613P
Indications: STAQUIS is indicated for topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

Product Name	EQUFINA FILM-COATED TABLETS 50MG
Active Ingredient	Safinamide
Application type	NDA-1: New chemical entity
Product Registrant	EISAI (SINGAPORE) PTE. LTD.
Date of Approval	28/09/2022
Registration No.	SIN16615P
Indications:	Improvement of wearing-off phenomenon in idiopathic Parkinson's disease currently treated with levodopa-containing products

Product Name	INREBIC CAPSULES 100MG
Active Ingredient	Fedratinib
Application type	NDA-1: New chemical entity
Product Registrant	Bristol-Myers Squibb (Singapore) Pte Ltd
Date of Approval	29 Sep 2022
Registration No.	SIN16617P
Indications:	Inrebic is indicated for the treatment of splenomegaly and/or disease related symptoms in adult patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, including patients who have been previously exposed to ruxolitinib.

Product Name	COMIRNATY, CONCENTRATE FOR DISPERSION FOR INJECTION, 3 MCG/DOSE
Active Ingredient	Tozinameran
Application type	NDA-2: New formulation and patient population
Product Registrant	BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE.LTD.
Date of Approval	28 Sep 2022
Registration No.	SIN16616P
Indications:	COMIRNATY is indicated for active immunisation to prevent COVID-19 caused by SARS CoV- 2 virus, in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.

Healthcare professional, Industry member, Therapeutic Products

Published: 28 Oct 2022

New Drug Approvals