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Dr. Bob is Robert Hsiung, MD,
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Posted by jrbecker on April 11, 2005, at 8:58:29
http://www.pharmalive.com/News/index.cfm?articleid=228195
FDA Issues Approvable Letter for AMBIEN CR (Zolpidem Tartrate Extended Release) CIV for the Treatment of Insomnia
PARIS, April 11, 2005 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for AMBIEN CR(TM) (zolpidem tartrate extended release) CIV. AMBIEN CR(TM) is the controlled-release formulation of zolpidem, the world's leading sleep aid(1).
An approvable letter outlines specific questions that have to be resolved before the Agency will approve a product for marketing.Sanofi-aventis Group is already working closely with the FDA to address the questions outlined in the letter. The FDA's questions relate specifically to AMBIEN CR(TM) and are not related to the safety and efficacy of AMBIEN(R) (zolpidem tartrate).
About Ambien(R)
AMBIEN(R) is indicated for the short-term treatment of insomnia. There is a low occurrence of side effects associated with the short-term use of AMBIEN(R). The most commonly observed side effects in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%). When you first start taking AMBIEN(R), use caution in the morning when engaging in activities requiring complete alertness until you know how you will react to this medication. In most instances, memory problems can be avoided if you take AMBIEN(R) only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again. As with any sleep medication, do not use alcohol while you are taking AMBIEN(R). Prescription sleep aids are often taken for 7 to 10 days-or longer as advised by your doctor. All people taking sleep medicines have some risk of becoming dependent on the medicine.
For full prescribing information, please visit http://www.ambien.com/
About sanofi-aventis
Sanofi-aventis Group is the world's 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi- aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic disorders, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New YorkThe sanofi-aventis Group conducts business in the U.S. through its affiliates Sanofi-Synthelabo Inc. and Aventis Pharmaceuticals Inc.
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by Sanofi-aventis and Aventis, including those listed under "Forward-Looking Statements" and "Risk Factors" in sanofi-aventis's annual report on Form 20-F for the year ended December 31, 2003 and those listed under "Cautionary Statement Regarding Forward-Looking Statements" and "Risk Factors" in Aventis's annual report on Form 20-F for the year ended December 31, 2003. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
U.S. Contact: Melissa Feltmann, 908-243-7080, melissa.feltmann@sanofi- aventis.com
CONTACT: Melissa Feltmann, sanofi-aventis, +1-908-243-7080,; Jean-Marc Podvin, +33-1-53-77-42-23, fax,+33-1-53-77-42-65 melissa.feltmann@sanofi-aventis.com
Web site: http://www.sanofi-aventis.com/http://www.ambien.com/
Company News On-Call: http://www.prnewswire.com/comp/232375.html
Ticker Symbol: (NYSE:SNY)
Terms and conditions of use apply
Copyright © 2005 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Posted by jrbecker on April 11, 2005, at 9:06:03
In reply to FDA Issues Approvable Letter for AMBIEN CR, posted by jrbecker on April 11, 2005, at 8:58:29
http://money.cnn.com/2005/04/11/news/international/sanofi.reut/
New sleeping pill gets delayed
Sanofi-Aventis faces a delay in launching Ambien CR to resolve certain issues with the FDA.
April 11, 2005: 8:42 AM EDT
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PARIS (Reuters) - Sanofi-Aventis SA faces a delay in launching Ambien CR -- a new form of its best-selling sleeping pill -- because U.S. regulators want more information on the product.Shares in the world's third-largest drugmaker fell as much as 1.8 percent Monday after it said it had received an "approvable" letter from the Food and Drug Administration (FDA) for the medicine, rather than full approval.
The move means it must resolve certain issues with the FDA before Ambien CR can be sold in the world's biggest market.
The French company said these issues were not related to the safety or effectiveness of Ambien CR, a new controlled-released version of its established blockbuster medicine Ambien, or Stilnox.
The already marketed version of Ambien faces competition from other sleeping drugs, such as Sepracor Inc's (Research) Lunesta, and is to lose its patent protection in October 2006, or in 2007 if it wins an extension for use by children.
Ambien sales were 1.42 billion ($1.8 billion) last year, up 15 percent compared with 2003.
Shares in Sanofi, which has said it hopes to launch Ambien CR in the United States by mid-2005, were down 1.5 percent at 66.50 by 1010 GMT after hitting a low of 66.30.
Sanofi has said it expects to file Ambien CR for European marketing approval by the middle of this year.
Its shares were also pressured by a downgrade from Credit Suisse First Boston, which cut its recommendation on the stock to "neutral" from "outperform," though with a maintained price target of 66.
The brokerage said the stock had rallied 15 percent so far this year and that the market needed reassurance on several uncertainties -- particularly threats to patents on Plavix and Allegra and questions about anti-obesity drug Acomplia -- to justify a further advance.
CSFB said there was also a risk that the recent strong rise in the share price might tempt block sales by major shareholder Total.
http://www.newratings.com/analyst_news/article_770784.html
Sanofi-Aventis Has Setback With Ambien CR
Monday, April 11, 2005 4:53:20 AM ET
Dow Jones Newswire
0838 GMT [Dow Jones] Sanofi-Aventis (SNY) suffers a setback on Ambien CR as FDA requests more information before allowing it to the market. "It's pretty bad because it delays the launch of this follow up to their blockbuster drug Ambien by at least six months," says Lombard Odier Darier Hentsch analyst. Ambien loses patent protection in '07. Delay leaves company with less time to switch patients over to the new version. Also, there's increasing competition for Ambien, he says. Not rated. Trades -1.3% at EUR66.65. (AAG)
Contact us in London.
+44-20-7842-9464
Markettalk.eu@dowjones.com
Posted by MidnightBlue on April 11, 2005, at 14:40:59
In reply to Approvable rather than approved = delayed launch, posted by jrbecker on April 11, 2005, at 9:06:03
Not sure what the difference is between the regular and the CR. Don't you suspect this is just a way to keep the patent? Isn't it about up?I mean Prilosec and Nexium aren't all that different and there are now THREE versions of Wellbutrin.
Posted by Spriggy on April 11, 2005, at 16:27:04
In reply to Re: Approvable rather than approved = delayed launch, posted by MidnightBlue on April 11, 2005, at 14:40:59
Okay am I the only one that cracks up when I read that the side effect reported on a SLEEPING medicine is "drowsiness?"
Anybody?
Posted by Phillipa on April 11, 2005, at 18:05:37
In reply to Re: Approvable rather than approved = delayed launch, posted by Spriggy on April 11, 2005, at 16:27:04
Interesting just when Lunesta is released. Fondly, Phillipa
Posted by jerrympls on April 11, 2005, at 18:20:31
In reply to Re: Approvable rather than approved = delayed launch, posted by Phillipa on April 11, 2005, at 18:05:37
> Interesting just when Lunesta is released. Fondly, Phillipa
the makers of Ambien are pulling out this CR version to compete with Lunesta. However, according to my pdoc - the makers of Lunesta are planning a HUGE HUGE marketing campaign to blow Ambien out of the water - especially since Ambien is only FDA approved for 7-10 days and Lunesta is approved for long-term use.
Posted by Phillipa on April 11, 2005, at 18:32:40
In reply to Re: Ambien vs. Lunesta, posted by jerrympls on April 11, 2005, at 18:20:31
I guess they are. Someone posted a link to their website and I registered when I was there. It's a beautiful butterfly flying about. So serene. I received my first newsletter from them today via E-mail and it was the same logo, and a lot of pages to click onto. That makes me leary. So much money to promote this med. I want to wait and see more reports from fellow Babblers. Fondly, Phillipa
Posted by jerrympls on April 11, 2005, at 18:40:42
In reply to Re: Ambien vs. Lunesta » jerrympls, posted by Phillipa on April 11, 2005, at 18:32:40
> I guess they are. Someone posted a link to their website and I registered when I was there. It's a beautiful butterfly flying about. So serene. I received my first newsletter from them today via E-mail and it was the same logo, and a lot of pages to click onto. That makes me leary. So much money to promote this med. I want to wait and see more reports from fellow Babblers. Fondly, Phillipa
Good idea not to jump into a med. I agree their site is very serene. I've even seen a commerical. They don't announce the product but instead say "Something new is coming to help you sleep...on April 24th." or something like that (not sure why they say April 24th).
Posted by Mandy on April 12, 2005, at 18:21:17
In reply to Re: Ambien vs. Lunesta » Phillipa, posted by jerrympls on April 11, 2005, at 18:40:42
I have had problems with ambien in that I kept increasing the dose and became addicted. I have never had this reaction to any other sleeping pill. I currently take Remeron 15mg at night for sleep since I have chronic insomnia. It helps me fall asleep but I cannot stay asleep and feel so tired every am. My psych is a little reluctant about Lunesta since I had problems with ambien. Does anyone know if Lunesta would be ok? The reason I increased ambien was to "zone out". I no longer want to do that, I just want a decent sleep. Does Lunesta cause the amnesia that ambien does? Thanks
Posted by Phillipa on April 12, 2005, at 18:25:46
In reply to Re: Ambien vs. Lunesta » jerrympls, posted by Mandy on April 12, 2005, at 18:21:17
It's supposed to be nonaddictive I believe. I'm waiting to read more reports. I have a couple of weeks before I see my pdoc. Fondly, Phillipa
Posted by jerrympls on April 12, 2005, at 19:48:40
In reply to Re: Ambien vs. Lunesta » Mandy, posted by Phillipa on April 12, 2005, at 18:25:46
> It's supposed to be nonaddictive I believe. I'm waiting to read more reports. I have a couple of weeks before I see my pdoc. Fondly, Phillipa
Well, you can become dependent on it like other sleep aids - however, it is approved for long-term use.
Posted by Phillipa on April 12, 2005, at 19:51:36
In reply to Re: Ambien vs. Lunesta, posted by jerrympls on April 12, 2005, at 19:48:40
Whoops! Just looked and I don't see my pdoc for 3 months. Guess I'll have to wait and see if they have samples. You can get addicted either mentally or physically to almost any drug. Sometimes I think if they gave me a placebo and told me it was a strong benzo I would sleep. I'm so suggestive. Fondly, Phillipa
Posted by empty inside on April 15, 2005, at 16:22:47
In reply to Re: Ambien vs. Lunesta » Phillipa, posted by jerrympls on April 11, 2005, at 18:40:42
> > I guess they are. Someone posted a link to their website and I registered when I was there. It's a beautiful butterfly flying about. So serene. I received my first newsletter from them today via E-mail and it was the same logo, and a lot of pages to click onto. That makes me leary. So much money to promote this med. I want to wait and see more reports from fellow Babblers. Fondly, Phillipa..
> Good idea not to jump into a med. I agree their site is very serene. I've even seen a commerical. They don't announce the product but instead say "Something new is coming to help you sleep...on April 24th." or something like that (not sure why they say April 24th).>
Yeah, I also know I shouldn't have gotten excited about Lunesta; just because it's new doesn't mean it's better than all the other sleeping meds I've tried but I have to admit when I read about it on here I asked my pdoc about it at my very next appt! lol. He wouldn't prescribe it because he said he didn't want any of his patients being "guinea pigs" so to speak -- didn't want to find out later about problems you know since it's so new, so he is waiting for more data as time goes by. I was disappointed but I guess it's for the best.
On the subject of Ambien, I used to take it and I don't recall needing a CR version because I remember sleeping thru the night although I needed 20mg. I haven't taken it in months because altho it works for me, it makes me hallucinate before I fall asleep. Really nasty, scary hallucinations. Unfortunately nothing else is working effectively for me lately -- been on so many drugs :(
This is the end of the thread.
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