deepsand562

It was announced that the EMSAM transdermal MAOI patch that uses selegiline was
marked "approvable" by the FDA today. It has made it out of phase 3 and now
must go thru a phase 4 marketing phase. Sounds like we are going to finally get
an MAOI patch, free of the MAOI diet!!!

This is probably the beginning of the end of the "me too" serotonin SSRI crap
drugs for depression. Finally we are getting an antidepressant that will
actually make you feel normal for a change!

http://www.watsonpharm.com/new/index.asp

Mylan Laboratories and Watson Pharmaceuticals Announce Receipt of 'Approvable'
Letter for EMSAM

PITTSBURGH & CORONA, Calif.--(BUSINESS WIRE)--Feb. 2, 2004--Mylan Laboratories
Inc. (NYSE:MYL - News) and Watson Pharmaceuticals, Inc. (NYSE:WPI - News)
announced today that Somerset Pharmaceuticals, Inc. has received an
"Approvable" letter from the U.S. Food and Drug Administration (FDA) for
EMSAM(TM) (selegiline transdermal system), the company's transdermal therapy
for which they are seeking an indication for the treatment of major depressive
disorder. Somerset is a joint venture between Mylan and Watson.
The FDA's letter indicates that Somerset has submitted sufficient data to
support the efficacy of EMSAM (20mg, 30 mg & 40mg) in the acute and maintenance
treatment of major depressive disorder. Somerset has initiated discussions with
the FDA to review and clarify its comments. These comments include that
Somerset conduct Phase 4 post-marketing pharmacokinetic and safety studies as
well as additional pharmacology/toxicology studies. In addition, Somerset will
initiate discussions with the FDA regarding proposed labeling, including FDA's
request to include labeling addressing tyramine dietary restrictions while
taking EMSAM.
"We will work diligently with the FDA on the specific additional requirements
needed to obtain approval of our EMSAM(TM) product," said Mel Sharoky, M.D.,
Somerset's president and chief executive officer. "With over 2,000 depressed
patients exposed to EMSAM, we are encouraged by the product's safety data and
view EMSAM as an important advance in the treatment of depression. At the same
time, Somerset will continue its discussions to out license EMSAM with a
potential partner."
Mylan Laboratories Inc.
Mylan Laboratories Inc. is a leading pharmaceutical company with four
subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL
Laboratories Inc. and Bertek Pharmaceuticals Inc., that develop, manufacture
and market an extensive line of generic and proprietary products.
For more information about Mylan, visit http://www.mylan.com.
Watson Pharmaceuticals, Inc.

There is hope afterall...praise God.

Eric

"Psychic derangements may appear when corticosteroids are used, ranging from
euphoria, insomnia, mood swings, personality changes and severe depression, to
frank psychotic manifestations." Direct quote from prednisone monograph insert.

.

I dunno - crikey!

"Two of its three principal metabolites, amphetamine and
methamphetamine, have pharmacological actions of their o.n. they
interfere with neuronal uptake and enhance release of several
neurotransmitters (e.g., norepinephrine, dopamine, serotonin). However,
the extent to which these metabolites contribute to the effects of
selegiline are unknown."
http://www.rxlist.com/cgi/generic/seleg_cp.htm

--
Regards,
..

deepsand562

<< Subject: Re: Selegiline MAOI patch FDA approved
From: . sdf329ds93s999990sx@yahoo.co.uk
Date: Tue, Feb 3, 2004 4:47 AM
Message-id: <MPG.1a8a0b2abf4826769896c9@News.CIS.DFN.DE>

I dunno - crikey!

"Two of its three principal metabolites, amphetamine and
methamphetamine, have pharmacological actions of their o.n. they
interfere with neuronal uptake and enhance release of several
neurotransmitters (e.g., norepinephrine, dopamine, serotonin). However,
the extent to which these metabolites contribute to the effects of
selegiline are unknown."
http://www.rxlist.com/cgi/generic/seleg_cp.htm

--
Regards,
..

Go the **** away anti-med asshole...

Eric


"Psychic derangements may appear when corticosteroids are used, ranging from
euphoria, insomnia, mood swings, personality changes and severe depression, to
frank psychotic manifestations." Direct quote from prednisone monograph insert.