Published: 6 March 2025
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Recent approvals: new active ingredients or new indications
Published: 6 March 2025
Prescriber Update 46(1): 14–15
March 2025
New active ingredients
Table 1 shows recent approval of medicines with new active ingredients gazetted during the period 18 October 2024 to 31 January 2025.
Table 1: Recent approvals of medicines with new active ingredients
| Medicine | New active ingredient | Dose form: strength(s) | Therapeutic area |
|---|---|---|---|
| Dayvigo | Lemborexant | Film coated tablet: 5mg, 10mg | Insomnia |
| Tevimbra | Tislelizumab | Concentrate for injection: 100mg/10mL | Oesophageal squamous cell carcinoma; Non-small cell lung cancer |
| Vyalev | Foscarbidopa + Foslevodopa | Solution for infusion: 12mg/mL + 240mg/mL | Parkinson’s disease |
| Winlevi | Clascoterone | Topical cream: 1% w/w | Acne vulgaris |
New indications
Table 2 shows approved medicines with new indications for additional therapeutic areas gazetted during the period 18 October 2024 to 31 January 2025.
Table 2: Approved medicines with new indications for additional therapeutic areas
| Medicine (active ingredient) | Dose form: strength(s) | New therapeutic area |
|---|---|---|
| Cosentyx (secukinumab) | Solution for injection: 75mg/0.5mL 150mg/mL 300mg/2mL Powder for injection: 150mg |
Hidradenitis suppurativa (acne inversa) |
| Enhertu (trastuzumab deruxtecan) | Powder for infusion: 100mg | Non-small cell lung cancer |
| Keytruda (pembrolizumab) | Concentrate for infusion: 25mg/mL | Biliary tract carcinoma; Merkel cell carcinoma |
| Skyrizi (risankizumab) | Concentrate for infusion: 600mg/10mL (vial) Solution for injection: 75mg/0.83mL (syringe) 150mg/mL (pen or syringe) 180 mg/1.2mL (cartridge) 360mg/2.4mL (cartridge) |
Ulcerative colitis |
More information
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