Posted by Deborah14 on October 27, 2000, at 16:16:39
In reply to Re: Selegeline Patch - Update?, posted by AndrewB on October 20, 2000, at 17:25:27
AndrewB
I keep trying to call Liberty Drug and all I get is a fast busy signal. Where are they located so I can get their local number, instead? What is a compounding pharmacist, specifically?I spoke with Dr. Bodkin and the clinical trials of the selegeline patch have been concluded. You are correct that the results will be submitted to the FDA sometime early next year. All the data has yet to be collected, collated and "tweaked" for submission to the FDA.
My concern is that the approval process is going to take more than the year predicted. Somerset is seeking FDA approval for not only the transdermal patch but use of l-deprenyl as a medication for the treatment of depression. This is a brand new submission to the FDA, under a new brand name. The submission for depression requires the drug to be submitted under a PMA and not under 510K approval, the later form of submission being much faster. The PMA requires the manufacturer to show first that l-deprenyl is safe and effective for the treatment of depression, and then seek approval for the patch as the delivery system.
I know quite a bit about the FDA approval process and I do not believe the submission of l-deprenyl as an anti-depressant is going to receive quick approval. Approval for the delivery system is not the problem for quick (relatively)approval. Since I don't have all the facts, I hope that my gut instrincts are wrong and that the patch gets approved by the end of 2001.
poster:Deborah14
thread:46818
URL: http://www.dr-bob.org/babble/20001022/msgs/47537.html