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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by jrbecker on June 26, 2003, at 14:29:06
FDA Issues Approvable Letter For Wellbutrin XL (Bupropion Hydrochloride) Extended Release Tablets
RESEARCH TRIANGLE PARK, NC and LONDON, ENGLAND -- June 26, 2003 -- GlaxoSmithKline announced today it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for the antidepressant Wellbutrin XL™ (bupropion hydrochloride extended-release tablets), which is under review for the treatment of major depressive disorder in patients aged 18 and older. GlaxoSmithKline is working with the FDA to clarify and resolve outstanding issues."The approvable letter involves resolution of routine matters and consequently we remain on track for approval of Wellbutrin XL during the second half of 2003. We believe that this product will provide an important new treatment option for adults with depression," said Stan Hull, Senior Vice President, GlaxoSmithKline.
GlaxoSmithKline licensed the once-daily formulation of bupropion hydrochloride from Biovail Corporation in October 2001.
SOURCE: GlaxoSmithKline
Posted by eep on June 26, 2003, at 17:08:02
In reply to FDA issues Approvable letter for Wellbutrin XL, posted by jrbecker on June 26, 2003, at 14:29:06
hi.
> FDA Issues Approvable Letter For Wellbutrin XL (Bupropion Hydrochloride) Extended Release Tablets
uhh, how is different than the SR version of wellbutrin? are they losing the patent on the SR pills already? or does the ER version eliminate multiple dosing schedules?
just curious,
v.
Posted by Snoozy on June 26, 2003, at 17:16:19
In reply to Re: Wellbutrin XL vs. SR, posted by eep on June 26, 2003, at 17:08:02
> uhh, how is different than the SR version of wellbutrin? are they losing the patent on the SR pills already? or does the ER version eliminate multiple dosing schedules?
>
> just curious,
> v.I was wondering the same thing! It sounds like the XL is once-a-day. But I would still be suspicious about the patent issue. SR, XL - it's sounding like a car! Maybe the XL comes with cruise control :)
Posted by paxvox on June 26, 2003, at 19:05:43
In reply to Re: Wellbutrin XL vs. SR, posted by Snoozy on June 26, 2003, at 17:16:19
Patent for the formulation of Wellbutrin has already expired. It is already available in the US as a generic (bupropion). Could be like the Celexa- Lexapro situation. Some SAY it is a NEW drug because of the pending expiration of Celexa's formulation, where others claim it's basically the same med (see posts regarding this in archieves). Personally, I see not need for any once a day formulation, if that's what it is, unless it would be cheaper for the patient. I have no problem taking two SR tabs per day, as a matter of fact, that way I can control WHEN I take the second dose so that it is not too close to my bedtime.
PAX
Posted by djmmm on June 26, 2003, at 19:36:37
In reply to Re: Wellbutrin XL vs. SR, posted by paxvox on June 26, 2003, at 19:05:43
> Patent for the formulation of Wellbutrin has already expired. It is already available in the US as a generic (bupropion). Could be like the Celexa- Lexapro situation. Some SAY it is a NEW drug because of the pending expiration of Celexa's formulation, where others claim it's basically the same med (see posts regarding this in archieves). Personally, I see not need for any once a day formulation, if that's what it is, unless it would be cheaper for the patient. I have no problem taking two SR tabs per day, as a matter of fact, that way I can control WHEN I take the second dose so that it is not too close to my bedtime.
>
> PAXIt is simply a clever marketing ploy, to avoid loss of sales. In fact, the FDA originally declined GlaxoSmithKline's "new" wellbutrin because it was the same slow release drug with a different name. Andrx Corp, the company that will make the generic version of the original wellbutrin SR has been experiencing production problems, GSK hopes to unveil the "new" wellbutrin before the generic sr is released.
Apparently, the FDA changed it's opnion when GSK presented new labeling for the "new" wellbutrin, which declares it a "once daily" medication devoid of the insomnia side-effects associated with the 2x day SR version....I suppose the "new" wellbutrin will come in a higher dose and be released "slower" than the sr version...
This is the end of the thread.
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