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Health Sciences Authority
New Drug Approvals

New drug approvals - January 2025

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

17 February 2025

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

  • Please click here 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.

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