New Drug Approvals

New drug approvals - January 2025

17 February 2025

Audiences

Healthcare professional

Industry member

Product-type

Therapeutic Products

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Please click here (opens in new tab) for a list of summary reports of benefit-risk assessments.

For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.

Drug caption

Product Name	GP CHOLECALCIFEROL SOFTGEL CAPSULE 25,000 IU
Active Ingredient (Strength)	Cholecalciferol(25,000IU)
Application type	NDA-2: New dosage form
Product Registrant	GOLDPLUS UNIVERSAL PTE LTD
Date of Approval	27/01/2025
Registration No.	SIN17171P
Indications: Treatment of clinically relevant vitamin D deficiency

Drug caption

Product Name	GRALISE EXTENDED RELEASE TABLETS 600 MG, GRALISE EXTENDED RELEASE TABLETS 300 MG
Active Ingredient (Strength)	Gabapentin(600.00 mg), Gabapentin(300.00 mg)
Application type	NDA-2/3: New dosage form
Product Registrant	LOTUS INTERNATIONAL PTE. LTD.
Date of Approval	16/01/2025
Registration No.	SIN17165P, SIN17166P
Indications: GRALISE is indicated for the management of postherpetic neuralgia. GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.