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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 6 of 6. This is the beginning of the thread.
Posted by Mystical on May 19, 2001, at 22:44:08
Pharmacia Receives “Not Approvable” Letter for VESTRA
~FDA Advisory committee to conduct review later this year~
Peapack, NJ (May 18, 2001) Pharmacia Corporation announced today that it has
received a “not approvable” letter from the U.S. Food and Drug Administration (FDA) for
VESTRA (reboxetine mesylate tablets), the company’s investigational antidepressant. The
company also announced that the FDA has agreed to convene an advisory committee
meeting of outside experts later this year to review the VESTRA submission.Pharmacia submitted its original NDA for VESTRA on April 29, 1998 based primarily on
the results of clinical studies conducted outside the U.S. At FDA’s request, the company
later conducted additional clinical studies in the U.S. and Canada. Results of these and
other previously completed studies supplemented the original filing at the FDA.VESTRA is a selective norepinephrine reuptake inhibitor (selective NRI) that affects the
norepinephrine chemical pathway in the brain. It is currently approved in 50 countries
around the world.Pharmacia Corporation (NYSE:PHA) is a top-tier global pharmaceutical company with a
leading agricultural subsidiary. Pharmacia’s innovative medicines and other products save
lives and enhance health and wellness. Pharmacia’s 59,000 people work together with
many diverse stakeholders to bring these benefits to people around the world, and to
create new health solutions for the future.
Analyst Contact :
Craig Tooman
Ph: (908) 901-8853
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Company: Pharmacia Corporation
Email: N/A
Media Contact :
Gail Thornton
Ph: (908) 901- 8598
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Company: Pharmacia Corporation
Email: N/A
Media Contact :
Paul Fitzhenry
Ph: (908) 901-8770
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Cell: N/A
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Company: Pharmacia Corporation
Email: N/A==================================================== AFTER ALL OUR WAITING, THIS IS REAL BUMMER! I THINK WE WE NEED TO START A REAL STRONG PHONE-IN AND WRITE-IN MOVEMENT TO THE FDA. WHAT DO YOU THINK? BRAD
Posted by SalArmy4me on May 19, 2001, at 22:48:55
In reply to Vestra (Reboxetine), posted by Mystical on May 19, 2001, at 22:44:08
Until reboxetine is approved, you can still use desipramine or maprotiline to get the norepinephrine you need. They just aren't as energizing as reboxetine.
Posted by kazoo on May 20, 2001, at 0:55:48
In reply to Vestra (Reboxetine), posted by Mystical on May 19, 2001, at 22:44:08
> AFTER ALL OUR WAITING, THIS IS REAL BUMMER! I THINK WE WE NEED TO START A REAL STRONG PHONE-IN AND WRITE-IN MOVEMENT TO THE FDA. WHAT DO YOU THINK? BRAD
^^^^^^^^^I try not to think in this group, Brad. This proves to be too dangerous at times.
Re. the FDA: "Dems are badddd ass!" And they're too callous and crass to pay any attention to us commoners. They couldn't care less. (While you're at it, get rid of the DEA as well!)
Instead of blaming the FDA for this shake-down, you should, instead, examine the profit margins of the Eli Lilly Company who had put the kibosh on VESTRA many months ago. Also realize that Lilly's new product, "PROZAC version 2," (duloxetine) is about to be released so the company had to hammer UPJOHN/Pharmacia Corporation in order to get the cutting edge on misery.
I was told that VESTRA is (or will be shortly) available in Canada, which is a helluvalot closer than the "old country" (Europe).
So, let us now praise famous corporations ... Eli Lilly (cough, cough, cough).
=======
Read all about it from "Medscape"...
=======New Lilly Drug Effective Against Major Depression
NEW YORK (Reuters Health) May 07 - With Eli Lilly's patent on the blockbuster
antidepressant fluoxetine (Prozac) set to expire, the firm on Monday released
late-stage data showing that a new product in its pipeline, duloxetine, safely and
effectively treats depression.Duloxetine is a dual reuptake inhibitor of serotonin and norepinephrine.
In an 8-week phase III study reported at the annual meeting of the American
Psychiatric Association in New Orleans, patients with major depression who
received 80 mg of duloxetine daily experienced significantly greater improvement in
depression symptoms than those who used placebo or 20 mg of paroxetine (Paxil),
a GlaxoSmithKline Plc drug, Eli Lilly said.The company said that 50% of duloxetine-treated patients achieved remission of
depression symptoms, versus 29.5% of patients receiving placebo. No figure was
given for those treated with paroxetine. The company also reported on a phase II
study that yielded similar results.Separately, GlaxoSmithKline said on Monday that paroxetine had been shown to
have a statistically significant effect in treating post-traumatic stress disorder.=========
Sort of makes you want to puke, you know?
(a hammered) kazoo
Posted by blackjack on May 20, 2001, at 20:38:45
In reply to Vestra (Reboxetine), posted by Mystical on May 19, 2001, at 22:44:08
Wel, ain't that just swell. Pharmacia obviously forgot to send out this month's bribe money...
Posted by loosmrbls on May 21, 2001, at 9:04:49
In reply to Vestra (Reboxetine), posted by Mystical on May 19, 2001, at 22:44:08
You've got to be careful here. We all know that as soon as the FDA approves this drug, millions of prescriptions will be written.
And they are responsible for saying "yea or nay." And trust me, other countires do not examine side-effect profiles of drugs nearly as close as the US does.
Should the FDA just let any prescription drug on the US market? If not, when is it "OK?"
Posted by kazoo on May 21, 2001, at 23:51:49
In reply to Re: Vestra (Reboxetine), posted by loosmrbls on May 21, 2001, at 9:04:49
> You've got to be careful here. We all know that as soon as the FDA approves this drug, millions of prescriptions will be written.
>
> And they are responsible for saying "yea or nay." And trust me, other countires do not examine side-effect profiles of drugs nearly as close as the US does.
>
> Should the FDA just let any prescription drug on the US market? If not, when is it "OK?"^^^^^^^^^^
On one hand, you are correct: ever since the THALIDOMIDE incident back in the 1950s, the FDA has kept a watchful eye on all new drugs ... can't have people being born with no arms or legs, you know!
However, on the other hand: the FDA did nothing to stop sale of REZULIN in the States after Europe pulled it off their shelves months prior (REZULIN, a diabetes medicine, was fingered in multiple cases of liver transplants and deaths).
FYI: http://www.rezulinnewsletter.com/default.htm
So, choose a pocket, any pocket ... whose pocket do you think the FDA is in? Warner-Lambert? Eli Lilly? Chuck E. Cheese?
Yes, Sir, that FDA (and DEA) are honorable institutions. Throw the bums out.
kazoo
This is the end of the thread.
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