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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 12 of 12. This is the beginning of the thread.
Posted by kazoo on February 11, 2000, at 2:40:30
Does anyone have any idea when this stuff is going to be released?
I was told some time during late summer.
I was also told that it's the Eli Lilly company who's putting
the screws to UPJOHN complaining to the FDA about the wording of
the packaging material. Is this nervy, or what?
Does Lilly fear a profit loss from this drug, Heaven's forbid?
Posted by Phil on February 11, 2000, at 6:13:27
In reply to Reboxetine...WHEN? Before I die?, posted by kazoo on February 11, 2000, at 2:40:30
I called the FDA WED. to go straight to the source. Hopefully will hear back today. The guy said the person he needed to check with was in another building and her mailbox was full! No shit.
Phil
Posted by jamie on February 11, 2000, at 7:53:08
In reply to Reboxetine...WHEN? Before I die?, posted by kazoo on February 11, 2000, at 2:40:30
You can get Reboxetine from a UK mailorder pharmacy. No problem. No prescription. It's not very expensive either. It has a good and safe reputation in countries where it is prescribed. The only drawback is about a 30 day wait for the shipment to arrive. But that's probably a lot sooner than the FDA will finally clear it.
Posted by CarolAnn on February 11, 2000, at 8:17:31
In reply to Reboxetine...WHEN? Before I die?, posted by kazoo on February 11, 2000, at 2:40:30
I've posted about this twice, but here it is again. I just saw my Pdoc Wednesday,(Feb. 9th), and he said that Reboxitine *is* scheduled to be approved within this year, possibly by the end of summer. He seemed very sure of his info, he was talking it up to me as something to try next, if my current meds. fail. Hope he's right! CarolAnn
Posted by Anon (hey kazoo...) on February 11, 2000, at 10:01:39
In reply to Re: Reboxetine...(this year, maybe), posted by CarolAnn on February 11, 2000, at 8:17:31
> I've posted about this twice, but here it is again. I just saw my Pdoc Wednesday,(Feb. 9th), and he said that Reboxitine *is* scheduled to be approved within this year, possibly by the end of summer. He seemed very sure of his info, he was talking it up to me as something to try next, if my current meds. fail. Hope he's right! CarolAnn
Well, as I have posted before, if the FDA comes back with an acceptable package insert language for P&U, it will come out in late Spring. Otherwise it will NEVER come out, as it is too expensive to re-do the trials to satisfy the FDA.I won't go into the current (unacceptable) package insert wording because it may be fixed soon, and if it isn't fixed it won't matter - P&U probably won't launch in the US.
Kazoo - are you from Kazoo (Kalamazoo, Michigan, former home of P & U)??
Posted by Vince on February 12, 2000, at 18:48:32
In reply to Re: Reboxetine...WHEN? Before I die?, posted by jamie on February 11, 2000, at 7:53:08
> You can get Reboxetine from a UK mailorder pharmacy. No problem. No prescription. It's not very expensive either. It has a good and safe reputation in countries where it is prescribed. The only drawback is about a 30 day wait for the shipment to arrive. But that's probably a lot sooner than the FDA will finally clear it.
Hey Jamie,
Could you give some specifics on that UK mail order pharmacy? Waiting for US approval is just becoming too ridiculous. Thanks
Posted by Leighwit on February 14, 2000, at 9:06:46
In reply to Re: Reboxetine...(this year, maybe), posted by Anon (hey kazoo...) on February 11, 2000, at 10:01:39
Having been on Reboxetine for a few weeks, I'd like to know the specifics about the labeling/package insert issue. Could you fill us in?
LW
Posted by Anon on February 14, 2000, at 12:46:54
In reply to Re: Reboxetine...(this year, maybe), posted by Leighwit on February 14, 2000, at 9:06:46
> Having been on Reboxetine for a few weeks, I'd like to know the specifics about the labeling/package insert issue. Could you fill us in?
>
> LWLet's just say that the FDA wants to include wording in the package insert that would cripple sales of the drug - cripple to the point that P&U is considering not even launching the drug in the US if they cannot persuade the FDA to change their minds.
Sorry, I won't go into specifics because the issue could be resolved (in which case it is a non-issue) or P&U will not launch (in which case it is also a non-issue).
Reboxetine would still be available from Europe, though.
Posted by jeff jarret on February 14, 2000, at 13:16:28
In reply to Re: Reboxetine...(this year, maybe), posted by Anon on February 14, 2000, at 12:46:54
> Sorry, I won't go into specifics because the issue could be resolved (in which case it is a non-issue) or P&U will not launch (in which case it is also a non-issue).
Anon you really dont know the specifics do you.
Posted by Anon on February 15, 2000, at 6:43:55
In reply to Re: Reboxetine...(this year, maybe), posted by jeff jarret on February 14, 2000, at 13:17:10
>
>
>
>
>
> > Sorry, I won't go into specifics because the issue could be resolved (in which case it is a non-issue) or P&U will not launch (in which case it is also a non-issue).
>
>
> Anon you really dont know the specifics do you.Actually, I do.
I also am an employee of Pharmacia & Upjohn, and do not wish that to be jeopardized. Revealing more could do just that.
I will say that there are two separate issues at work -
The efficacy issue (discussed on this board) where Reboxetine and Prozac both were found to be no better than placebo - probably due to a poorly designed study or unbelievable bad luck.
Then there is the safety issue, where an unexpected side effect appeared in a handful of patients undergoing trials. This side effect did not appear in testing or actual clinical use in Europe, and is probably due to bad luck - all side effects during trials must be reported, whether or not the drug caused them...the FDA suggested regular testing for this side effect for those taking the drug. P&U felt this would cause most docs to not even prescribe the drug.
I know it is frustrating to those wanting more, but look at it from my point of view - would you put your job in danger to please a few souls you have never even met?
Anon
Posted by PL on February 15, 2000, at 9:08:40
In reply to Re: Reboxetine...(this year, maybe), posted by Anon on February 15, 2000, at 6:43:55
...
Posted by Leighwit on February 16, 2000, at 15:04:06
In reply to Nuff Said, posted by PL on February 15, 2000, at 9:08:40
Posted by PL on February 15, 2000, at 9:08:40
In reply to Re: Reboxetine...(this year, maybe), posted by Anon on February 15, 2000, at 6:43:55>> NUFF SAID
>> ...Probably a good bet that PL isn't taking Reboxetine
" ... "
This is the end of the thread.
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