New drug approvals - January 2025
- 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.
| 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 |
| 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. |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Approvals