3 September 2015 - The TGA registered two new medicines in August 2015. Summary information on the registration of these medicines in Australia, the US and the European Union is provided in the table below.
Medicine (generic name) | Sonidegib diphosphate | Siltuximab |
Medicine (brand name) | Odomzo | Sylvant |
Sponsor | Novartis | Janssen-Cilag |
Disease/condition | Basal cell carcinoma | Castleman's disease |
Orphan drug (TGA) | No | Yes |
Date of TGA approval | 10 August 2015 | 31 August 2015 |
Date of FDA approval | 24 July 2015 | 22 April 2014 |
Date of EC approval | 14 August 2015 | 22 May 2014 |