New drug approvals - January 2024

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Product Name

GENCEBOK SOLUTION FOR INFUSION 10MG/ML

Active Ingredient (Strength)

Caffeine Citrate(10.00mg/ml)

Application type

NDA-2

Product Registrant

AXXESSBIO PTE. LTD.

Date of Approval

16/01/2024

Registration No.

SIN16929P

Indications:

Treatment of primary apnoea of premature newborns.

 

Product Name

LUMIGAN PF (BIMATOPROST OPHTHALMIC SOLUTION) 0.03%

Active Ingredient (Strength)

Bimatoprost(0.3 mg/mL)

Application type

NDA-2

Product Registrant

ABBVIE PTE. LTD.

Date of Approval

30/01/2024

Registration No.

SIN16938P

Indications:

LUMIGAN® 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.

 


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New Drug Approvals