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Dr. Bob is Robert Hsiung, MD,
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Posted by ed_uk on October 11, 2005, at 16:42:32
Here is some info courtesy of jrbecker (from a babblemail)...........
Ramelteon is still actually in phase III trials in the EU, and one
would hope that they are nearing completion by the end of the year, but you
never know. For last year, the average turn-around for approval of
human medicines was about 14 months. However, seeing that this is a
somewhat benign drug compound, we can probably predict to see it approved
earlier. Once submitted, the EMEA will grant an opinion a couple of months
before the European Commission approves it, so you should hear progress
before it actually launches. But at the very least, you're probably
looking well into 2006 at this point.As for Zolpidem CR, to be branded as Stilnoxium(TM) there, an extension
was submitted to the Mutual Recognition Procedure (MRP) in March of
this year. Unfortunately, I'm not really familiar with the typical timing
of this procedure. Also, I'm not quite sure if an MRP approval
supersedes an EMEA application. What I do know is that an MRP is sort of a
consortium approval of the different countries' health institutions and
that it also helps to set up pricing and insurance reimbursement
procedures in the EU. So perhaps this means that once the MRP is granted, it
will go straight to market.
Posted by Tom Twilight on October 12, 2005, at 15:52:49
In reply to Ambien CR, Rozerem and the UK, posted by ed_uk on October 11, 2005, at 16:42:32
a
This is the end of the thread.
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