New drug approvals – Jan 2024

Product NameGENCEBOK SOLUTION FOR INFUSION 10MG/ML
Active Ingredient (Strength)Caffeine Citrate(10.00mg/ml)
Application typeNDA-2
Product RegistrantAXXESSBIO PTE. LTD.
Date of Approval16/01/2024
Registration No.SIN16929P
Indications:Treatment of primary apnoea of premature newborns.
Product NameLUMIGAN PF (BIMATOPROST OPHTHALMIC SOLUTION) 0.03%
Active Ingredient (Strength)Bimatoprost(0.3 mg/mL)
Application typeNDA-2
Product RegistrantABBVIE PTE. LTD.
Date of Approval30/01/2024
Registration No.SIN16938P
Indications:LUMIGANยฎ Preservative Free 0.03% (bimatoprost ophthalmic solution) is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

HSA: Health Sciences Authority

Link to the HSA announcement: https://www.hsa.gov.sg/announcements/new-drug-approval/new-drug-approvals—january-2024


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