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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 3 of 3. This is the beginning of the thread.
Posted by Boba Fat on June 10, 2003, at 3:57:36
I am curious in these next gen Antidepressants, anxyiolitics. Does anyone know when these three drugs will be on the market, especially with regards to England. I know that approval for pregabalin has already been filed. How long does this approval process take?
Any info much appreciated. Thankyou.
Posted by pseudonym on June 11, 2003, at 1:27:42
In reply to Duloxetine/pregabalin/substance p antagonists, posted by Boba Fat on June 10, 2003, at 3:57:36
I too would like to know this, especially with regard to the European approval of pregabalin. What is the governing body in Europe which needs to pass judgement on pregabalin? As an aside, its simply astounding the amount of time since the discovery of a next-generation anxiolytic compound in 1989 until its assumed approval 15-16 years later. Nearly every night I read, or at least search, for the next generation of anxiolytic compounds, and am amazed at the level of knowledge regarding GABA A anxiolytic receptor subtypes and not a single approved compound which uses this mechanism of action.
> I am curious in these next gen Antidepressants, anxyiolitics. Does anyone know when these three drugs will be on the market, especially with regards to England. I know that approval for pregabalin has already been filed. How long does this approval process take?
>
> Any info much appreciated. Thankyou.
Posted by jrbecker on June 12, 2003, at 21:02:53
In reply to Re: Duloxetine/pregabalin/substance p antagonists, posted by pseudonym on June 11, 2003, at 1:27:42
As of reports dated june 11th, duloxetine is still on for fourth quarter. However, I read one financial report today from a top analyst that predicts it will be cleared for marketing prior to 4Q. When I have my appt with my pdoc in 2 weeks, I will ask if he knows whether there has been any new hints from his Lilly reps of a more finite date.
http://reuters.com/financeNewsArticle.jhtml?storyID=2912328&type=companyResultsNews
Lilly still expects 4th-qtr Cymbalta approval
Wed June 11, 2003 09:53 AM ET
NEW YORK, June 11 (Reuters) - Eli Lilly and Co. on Wednesday said it continues to expect U.S. approval of its experimental depression drug Cymbalta by the fourth quarter, following recent inspections by regulators of the plant where the drug is made.
Lilly LLY.N spokesman Rob Smith said the U.S. Food and Drug Administration inspected the Indianapolis plant on May 5, a necessary step before Cymbalta can be approved. Smith said Lilly may need to take additional steps to satisfy FDA quality-control requirements, but the company continues to expect U.S. approval of the drug by the fourth quarter.
This is the end of the thread.
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