New Drug Indication Approvals

New drug indication approval - October 2025

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Healthcare professional

Industry member

Product type

Therapeutic Products

11 December 2025

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

Drug caption

Product Name	EPKINLY CONCENTRATE FOR SOLUTION FOR INJECTION 4MG/0.8ML, EPKINLY SOLUTION FOR INJECTION 48MG/0.8ML
Active Ingredient (Strength)	Epcoritamab(4.0mg/0.8mL), Epcoritamab(48mg/0.8mL)
Product Registrant	ABBVIE PTE. LTD.
Date of Approval	30/10/2025
Indications: EPKINLY is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Drug caption

Product Name	XTANDI™ SOFT CAPSULES 40MG
Active Ingredient (Strength)	Enzalutamide(40.0 mg)
Product Registrant	ASTELLAS PHARMA SINGAPORE PTE. LTD.
Date of Approval	21/10/2025
Indications: Xtandi is indicated as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.

Drug caption

Product Name	RYBREVANT CONCENTRATE FOR SOLUTION FOR INFUSION 350MG/7ML
Active Ingredient (Strength)	Amivantamab(350mg/7ml)
Product Registrant	JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Date of Approval	01/10/2025
Indications: RYBREVANT® is indicated: • in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. * Evaluated via Project ORBIS

Drug caption

Product Name	AMVUTTRA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 25MG
Active Ingredient (Strength)	Vutrisiran (as vutrisiran sodium)(25mg)
Product Registrant	MEDISON PHARMA SINGAPORE PTE. LTD.
Date of Approval	31/10/2025
Indications: Amvuttra is indicated for the treatment of hereditary transthyretin amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy (hATTR-PN). Amvuttra is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

Drug caption

Product Name	GONAL-F 150 IU/0.25 ML (11 MICROGRAMS/0.25 ML) SOLUTION FOR INJECTION IN PRE-FILLED PEN, GONAL-F 300 IU/0.5 ML (22 MCG/0.5 ML) SOLUTION FOR INJECTION IN A PRE-FILLED PEN, GONAL-F 450 IU/0.75 ML (33 MCG/0.75 ML) SOLUTION FOR INJECTION IN A PRE-FILLED PEN, GONAL-F 900 IU/1.5 ML (66 MCG/1.5 ML) SOLUTION FOR INJECTION IN A PRE-FILLED PEN
Active Ingredient (Strength)	Follitropin alfa(11.115 μg/0.25ml), Follitropin alfa(22.23 mcg), Follitropin alfa(33.34 mcg), Follitropin alfa(66.69 mcg)
Product Registrant	MERCK PTE. LTD.
Date of Approval	16/10/2025
Indications: In adult women • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate. • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer. In adult men • GONAL-f is indicated for the stimulation of spermatogenesis in men who have hypogonadotrophic hypogonadism (congenital or acquired) with concomitant human chorionic gonadotropin (hCG) therapy.

Drug caption

Product Name	ASACOL TABLET 800MG
Active Ingredient (Strength)	Mesalazine(800mg)
Product Registrant	WELLCHEM PHARMACEUTICALS PTE LTD
Date of Approval	28/10/2025
Indications: Asacol is indicated in adults, children and adolescents 6 years of age and older for: Ulcerative colitis (colitis, rectosigmoiditis and proctitis): For the treatment of acute exacerbations. For the maintenance of remission.

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