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tetrabenzaine FDA approval

Posted by Debra 
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Debra
tetrabenzaine FDA approval
February 07, 2008 08:58PM
Just heard that tetrabenazine was FDA approved!!!!
My husband was in the Tetrabenazine Clinical trial. He received a call today that it was approved.
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Barb
Re: tetrabenzaine FDA approval
February 07, 2008 09:00PM
Oh my gosh!!!!!! Fantastic!
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yzrabbit1
Re: tetrabenzaine FDA approval
February 07, 2008 09:07PM
Wow I can't believe it. Finally 1 drug.
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stevei
Re: tetrabenzaine FDA approval
February 07, 2008 09:33PM
Congratulations and many thanks to everyone who played a role in making this happen. Especially the unbelievably persistent Nancy Wexler, her team and all of the researchers who were involved.

Steve I
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Rowan
Re: tetrabenzaine FDA approval
February 08, 2008 09:39AM
in a nut shell, what does tetrabenzaine do or how does it help?
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sweetwes
Re: tetrabenzaine FDA approval
February 08, 2008 10:42AM
Rowan- I think it helps with movements.

My mom takes it right now, but we have to order from India, I think its kinda dumb we have to order from there... This is good news for us smiling smiley
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Rowan
Re: tetrabenzaine FDA approval
February 08, 2008 11:43AM
does it make a noticeable difference in the movements?
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kt71481
Re: tetrabenzaine FDA approval
February 08, 2008 12:06PM
I e-mailed a woman from the Tetrabenazine drug company and she said that although the FDA's advisory committee voted to recommend approval of the drug (Dec 6, 2007), the FDA has not approved it yet. But there's high hopes for receiving approval this year.
And we need it!
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yzrabbit1
Re: tetrabenzaine FDA approval
February 08, 2008 12:11PM
Rowan Wrote:
-------------------------------------------------------
> does it make a noticeable difference in the
> movements?


I think it does in some people but not everyone. It's hit or miss. I do not know what the % of people helped is. Maybe someone else does? I have seen one man with HD that was virtually movement free after using it.
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Marsha
Re: tetrabenzaine FDA approval
February 08, 2008 01:17PM
I keep checking the FDA website, Google News, and the Prestwick website. I haven't seen or heard anything about approval yet and neither has the HDSA staff. But it's possible that there could be an announcement soon because I know that there's been an effort to inform trial participants about news before public announcements are made.

In any case, we should hear something soon and I'm working on an update so one will be ready to go as soon as we hear something.
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Dave
Re: tetrabenzaine FDA approval
February 08, 2008 03:11PM
It's not the only drug that can control chorea, so if you're uncomfortable with chorea, talk to your doctor.
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Sally
Re: tetrabenzaine FDA approval
February 08, 2008 08:05PM
What does this mean for Canadians? Anything?
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Barb
Re: tetrabenzaine FDA approval
February 08, 2008 08:09PM
It's already approved here in canada sally, that's why right now americans have to buy it from us or from other places
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skmf12
Re: tetrabenzaine FDA approval
February 10, 2008 10:44PM
MARSHA,

COULD YOU DO A WHOLE NEW WRITE UP ON THE TETRABENAZINE, WHEN YOU GET THE WORD, WITH A FULL EXPLANAIION IN LAYMENS TERMS?

WE SHOULD HAVE A CELEBRATION, A CONTEST OR SOMETHING FUN, k?

HEY MISS YOU GUYS...
(just taking a break from stuff...)

I'm your cheerleader I miss you

p.s... could we get some new smileys now?
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Marsha
Re: tetrabenzaine FDA approval
February 10, 2008 11:04PM
Yes, there will be a whole new TBZ write up when the approval is granted.....BUT I just talked to someone who went to the CHDI meeting last week and the FDA representative said that the decision has not been made yet.
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roto1
Re: tetrabenzaine FDA approval
February 12, 2008 08:19PM
I was told today that they are writing prescriptions in the USA now and insurance in covering it.
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JFB
Re: tetrabenzaine FDA approval
March 11, 2008 06:56PM
Just left from first DR's visit and it is not covered by insurance (and not approved to be prescribed)

However it is available for experimental use. (had to sign waivers and forms)

Should I let wife take it? (i've already paid for it)
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Marsha
Re: tetrabenzaine FDA approval
March 11, 2008 07:14PM
It is not yet FDA approved. TBZ is a tricky drug. If someone is not already taking an antidepressant, it can send them into a tailspin. You need to start an antidepressant if she's not already on one, and start with a low dosage of the TBZ and work up. Also watch for any cognitive problems.
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JFB
Re: tetrabenzaine FDA approval
March 11, 2008 08:08PM
Thanks for the quick reply.

I just got home when i posted. I have since read medication notes and have the same concern, especially since the wife talks of sucide frequently.

The Dr provided a medication matrix sheet and we do start with an SSRI, gradually increasing its dose for a week prior to starting TBZ at 6mg/day and then increase each week.

i had asked for memantine, but the Dr said TBZ was his recomendation

Thanks
Joe
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sweetwes
Re: tetrabenzaine FDA approval
March 12, 2008 08:34AM
man, I hope this gets here fast, my mom needs this drug, it really helps, but it cost a small fortune right now to order. I hope it gets cheaper once approved for the U.s.
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