NADH FDA REPLY

[Ralph Reichert <ral@xxxxxxxxxxxxx>]

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>Date: Mon, 15 Dec 1997 08:59:35 -0500 (EST)
>From: Account CDEREXSEC <CDEREXSEC@xxxxxxxxxxxx>
>Subject: NADH
>To: ral@xxxxxxxxxxxxx
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>Posting-date: Mon, 15 Dec 1997 08:59:36 -0500 (EST)
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>
>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"
><web@xxxxxxxxxxx> 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     ral@xxxxxxxxxxxxx
>------------------------------------------------------------
>