Suprelorin® has been on sale in Australia since December 2004 – is the product in the process of obtaining US and EU approval?
The FDA registration process has begun and we are conversing with the FDA to ensure that the product we manufacture and the clinical trial design is acceptable to the FDA. We have already submitted a dossier to the EU and have received a reply from them already. We are currently compiling a series of responses to them, and expect to have this completed by mid-late 2006. Note that we must also provide these authorities with data from batches manufactured in our new facility over the next few months as the original dossier contained data from our previous site.
Related Questions
- Suprelorin® has been on sale in Australia since December 2004 - is the product in the process of obtaining US and EU approval?
- What if sponsors have applied for different terms of approval in Australia and New Zealand for the same product?
- Is there an approval process a department should adhere to before producing any product?
