New Drug Indication Approvals

New drug indication approval - December 2025

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

2 February 2026

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

Drug details

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.

Drug details

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.

Drug details

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

Drug details

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.

Drug details

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.

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