Posted by Michael Wonder on 01 Oct 2015
Registration of NCEs by the TGA - September 2015
1 October 2015 - The TGA registered three new medicines in September 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) | Nintedanib esylate | Atazanavir sulphate with cobicistat | Darunavir ethanolate with cobicistat |
| Medicine (brand name) | Ofef/Vargatef | Evotaz | Prescobix |
| Sponsor | Boehringer Ingelheim | Bristol-Myers Squibb | Janssen-Cilag |
| Disease/condition | Non small-cell lung cancer and idiopathic pulmonary fibrosis | HIV infection | HIV infection |
| Orphan drug (TGA) | No | No | No |
| Date of TGA approval | 1 September 2015 | 23 September 2015 | 24 September 2015 |
| Date of FDA approval | Not registered, 2 January 2015 | 29 January 2015 | 29 January 2015 |
| Date of EC approval | 21 November 2014, 15 January 2015 | 21 May 2015 | 19 November 2014 |
