New drug indication approval - December 2025
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| Product Name | BOTOX® POWDER FOR SOLUTION FOR INJECTION 50 UNITS/VIAL,
BOTOX POWDER FOR SOLUTION FOR INJECTION 100 UNITS/VIAL,
BOTOX® POWDER FOR SOLUTION FOR INJECTION 200 UNITS/VIAL |
| Active Ingredient (Strength) | Clostridium Botulinum toxin type A(50 Units),
CLOSTRIDIUM BOTULINUM TOXIN TYPE A(100 units/vial),
Botulinum toxin type A(200 Units) |
| Product Registrant | ABBVIE PTE. LTD. |
| Date of Approval | 10/12/2025 |
Indications:
BOTOX® is indicated for the temporary improvement in the appearance of moderate to severe platysma prominence seen at maximum contraction and associated with platysma muscle activity in adults. |
| Product Name | TEZSPIRE SOLUTION FOR INJECTION 210 MG IN PRE-FILLED SYRINGE,
TEZSPIRE SOLUTION FOR INJECTION 210 MG IN PRE-FILLED PEN |
| Active Ingredient (Strength) | Tezepelumab(210 mg/unit),
Tezepelumab(210 mg/unit) |
| Product Registrant | ASTRAZENECA SINGAPORE PTE LTD |
| Date of Approval | 29/12/2025 |
Indications:
TEZSPIRE is indicated as an add-on therapy to intranasal corticosteroids for the treatment of adult patients with inadequately controlled severe CRSwNP. |
| Product Name | CABOMETYX FILM COATED TABLET 20MG,
CABOMETYX FILM COATED TABLET 40MG,
CABOMETYX FILM COATED TABLET 60MG |
| Active Ingredient (Strength) | Cabozantinib (S)-malate 25.34mg eqv Cabozantinib(20mg),
Cabozantinib (S)-malate 50.69mg eqv Cabozantinib(40mg),
Cabozantinib (S)-malate 76.03mg eqv Cabozantinib(60mg) |
| Product Registrant | IPSEN PHARMA SINGAPORE PTE. LTD. |
| Date of Approval | 15/12/2025 |
Indications:
CABOMEYTX is indicated for the treatment of adult patients with locally advanced unresectable or
metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) or extra-pancreatic
neuroendocrine tumours (epNET) who have progressed following at least one prior systemic therapy
other than somatostatin analogues.
* Evaluated via Project ORBIS |
| Product Name | REKAMBYS PROLONGED-RELEASE SUSPENSION FOR INJECTION 300MG/ML |
| Active Ingredient (Strength) | Rilpivirine(300mg/mL) |
| Product Registrant | JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD |
| Date of Approval | 24/12/2025 |
Indications:
REKAMBYS® is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. |
| Product Name | RYALTRIS NASAL SPRAY 600/25MCG |
| Active Ingredient (Strength) | MOMETASONE FUROATE MONOHYDRATE (MICRONIZED) EQV TO MOMETASONE FUROATE(25 MCG/SPRAY),OLOPATADINE HCL EQV TO OLOPATADINE(600 MCG/SPRAY) |
| Product Registrant | LOTUS INTERNATIONAL PTE. LTD. |
| Date of Approval | 30/12/2025 |
Indications:
RYALTRIS® is indicated for the treatment of moderate to severe symptoms associated with allergic rhinitis and rhinoconjunctivitis in patients 6 years of age and older. |
Healthcare professional, Industry member, Therapeutic Products
Published:
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New Drug Indication Approvals