 |
 |
>MR-Received: by mta DONALD; Relayed; Mon, 15 Dec 1997 08:59:02 -0500 >Alternate-recipient: prohibited >Date: Mon, 15 Dec 1997 08:59:35 -0500 (EST) >From: Account CDEREXSEC <[log in to unmask]> >Subject: NADH >To: [log in to unmask] >MIME-version: 1.0 >Posting-date: Mon, 15 Dec 1997 08:59:36 -0500 (EST) >Importance: normal >Priority: normal >Sensitivity: Company-Confidential >A1-type: MAIL >Hop-count: 1 > > >Dear Dr. Reichert: > >Thank you for your message (copied below), which was forwarded to us in >the Center for Drug Evaluation and Research for reply. > >As you probably know, NADH is not at this time the subject of an >approved new drug application (NDA) for any indication. But further, >confidentiality rules probit us from commenting on any product or >application prior to approval (including the existance of an >application) unless the information has previously been made public. >So, I am sorry, but I cannot answer your question. > >The term "in the pipeline" generally refers to products under >development, but there is also a book called The NDA Pipeline, published >annually by the F-D-C reports, which compiles information from the trade >publication called The Pink Sheet. In the latest edition available, >which is the 16th for 1996, NADH is listed as being under development by >the Telluride Pharmceutical Corporation for memory loss and/or >Alzheimer's Disease. You may wish to contact them directly at >908/359-1375 for information on the current status of their development >program. > >Please do not hesitate to contact us again if we can be of some further >assistance. > >Sincerely, > >Lee L. Zwanziger >Executive Secretariat Team Leader >Center for Drug Evaluation and Research > > > > >- - - - - - - - - - - - - - Original Message - - - - - - - - - - - - - - >To: Webmail@OPA-COMM@FDAOC From: "WEB Daemons" ><[log in to unmask]> Date: Wednesday, December 10, 1997 at >10:55:14 >am EST Attached: None > >Sent by: Ralph Reichert, MD > E-mail: > >Comment about The FDA WWW server: >------------------------------------------------------------ Please >advise if FDA is in process of evaluating NADH (a co-enzyme or >vitamin-like substance) which has been used in Germany for treatment of >Parkinson's disease and other neurodegenerative disorders. There have >been comments sent to the Parkinson's disease Listserve that indicate >that NADH is in the FDA pipeline and I would like to know if that is >true. If NADH IS being investigated, please inform me as to it's >status. Thank you. R. Reichert, MD [log in to unmask] >------------------------------------------------------------ >