Published: 1 June 2023
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Recent approvals: new active ingredients or new indications
Published: 1 June 2023
Prescriber Update 44(2): 40–41
June 2023
Table 1 shows recent approval of medicines with new active ingredients and Table 2 shows approved medicines with new indications for additional therapeutic areas. These medicines were gazetted during the period 21 December 2022 to 6 April 2023.
Table 1: Recent approvals of medicines with new active ingredients
| Medicine | New active ingredienta | Dose form: strength(s) | Therapeutic area |
|---|---|---|---|
| Comirnaty Original/ Omicron BA.1b |
Riltozinameran | Suspension for injection: 15mcg + 15 mcg/0.3mL | COVID-19 prevention |
| Comirnaty Original/ Omicron BA.4-5b |
Famtozinameran | Suspension for injection: 15mcg + 15 mcg/0.3mL | COVID-19 prevention |
| Diacomit | Stiripentol | Capsule: 250mg, 500 mg Powder for oral suspension: 250mg, 500mg |
Severe myoclonic epilepsy in infancy (Dravet syndrome) |
| Leqvio | Inclisiran | Solution for injection: 284mg/1.5mL | Cardiovascular disease |
| Orkambi | Lumacaftor | Tablet: 100mg + 125mg, 200mg + 125mg Granules: 100mg + 125mg, 150mg + 188mg |
Cystic fibrosis |
| Ozempic | Semaglutide | Solution for injection: 1.5mL, 3mL | Type 2 diabetes |
| Qinlock | Ripretinib | Tablet: 50mg | Gastrointestinal stromal tumours |
| Vazkepa | Icosapent | Capsule: 998mg | Cardiovascular disease |
| Yondelis | Trabectedin | Powder for infusion: 0.25mg, 1 mg | Liposarcoma or leiomyosarcoma |
- The medicine may also contain other active ingredients
- Provisional approval
Table 2: Approved medicines with new indications for additional therapeutic areas
| Medicine (active ingredient) | Dose form and strength(s) | New therapeutic area |
|---|---|---|
| Cosentyx (secukinumab) | Solution for injection: 75mg/0.5mL, 150mg/mL, 300mg/2mL
Powder for injection: 150mg |
Juvenile idiopathic arthritis |
| Nucala (mepolizumab) | Powder for injection: 100 mg/mL Solution for injection (pre-filled pen and pre-filled syringe): 100 mg/mL |
Chronic rhinosinusitis with nasal polyps, hypereosinophilic syndrome |
See the Medsafe website for:
