Posted by SLS on February 20, 2001, at 14:47:28
Pfizer is currently proposing that the trade name for their drug ziprasidone will be "Geodon".Ziprasidone is an atypical neuroleptic antipsychotic developed for use in schizophrenia. It can be characterized as being like Zyprexa, but WITHOUT WEIGHT GAIN. Hopefully, it will work as touted. Regarding the lack of weight gain, the studies that I have come across support this claim. Ziprasidone has been the most extensively studied and clinically tested of any psychotropic drug to date.
It is very possible that, like Zyprexa and Risperdal, ziprasidone will prove to be a very valuable tool in treating depression and bipolar disorder. On paper, ziprasidone would have an even greater potential as an antidepressant than Zyprexa.
- Scott-----------------------------------------------------------
NDA 20-825 Approval Letter and Labeling
2/5/01 01:27:06 PM
"As stated in the action letter of September 8, 2000, the proprietary name "Zeldox" is not in compliance with 21 CFR 201.10(c)(5). This regulation prohibits the designation of a drug or ingredient by a proprietary name that, because of similarity in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient. However, your proposed alternative proprietary name "Geodon" is acceptable. Please note, if you choose not to use "Geodon" as the proprietary name for this product, the name you choose and its use in the label must conform to the specifications under 21 CFR 201.10 and 201.15. Please submit any proprietary name to the Agency for our review prior to its implementation."
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poster:SLS
thread:54504
URL: http://www.dr-bob.org/babble/20010212/msgs/54504.html