Registration of NCEs by the TGA - August 2015

TGA

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
Michael Wonder

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Michael Wonder