Forgive me, I am a little naive when it comes to drug approval, well
actually I have worked for Wyeth-Ayerst, Dupont pharma and Smith Kline
but I do not know much about getting a drug that has been around for
while in other countries approved here in the u.s.
Would they acutally have to do the entire process for approval?  there
isnt anyway to take the information from other countries (assuming some
studies have been done there) and just apply here for approval?  I just
cannot believe that since cisapride was taken off the market and due to
the side effects of Reglan (metoclopramide) that they cannot find a
market for this drug in the u.s.???
JP

> Date:    Fri, 11 Jun 2004 07:34:04 EDT
> From:    "Pat Lindsey, IBCLC" <[log in to unmask]>
> Subject: Domperidone, J & J and Janssen Cilag
>
> called Tom Hale to discuss seeing if we could get Janseen to apply
> to FDA to
> have domperidone approved in US. Tom called Janssen in Itlay and
> spoke to
> Janssen Cilag's VP who told him it had been discussed at many board
> meeting, even
> the past board meeting and was considered too expensive to apply to
> US FDA and

             ***********************************************

To temporarily stop your subscription: set lactnet nomail
To start it again: set lactnet mail (or digest)
To unsubscribe: unsubscribe lactnet
All commands go to [log in to unmask]

The LACTNET mailing list is powered by L-Soft's renowned
LISTSERV(R) list management software together with L-Soft's LSMTP(R)
mailer for lightning fast mail delivery. For more information, go to:
http://www.lsoft.com/LISTSERV-powered.html