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Ed. Note: The following is a press release issued by Pfizer, Inc.
Pfizer Submits New Drug Application for Pregabalin for the Treatment Of
Neuropathic Pain, Generalized Anxiety Disorder and Partial Seizures
Friday October 31, 8:47 am ET
NEW YORK, Oct. 31 -- Pfizer Inc announced today that
it has submitted a New Drug Application (NDA) with the U.S. Food and Drug
Administration seeking approval for pregabalin for the management of
neuropathic pain associated with diabetic peripheral neuropathy (DPN) and
herpes zoster (post-herpetic neuralgia), generalized anxiety disorder and
adjunctive therapy for partial seizures in patients with epilepsy.
Developed by Pfizer, pregabalin has a unique mechanism of action for
potential treatment of certain neurologic and psychiatric disorders.
Neuropathic pain and generalized anxiety disorder are highly prevalent,
under- diagnosed and under-treated conditions. There is currently no
approved treatment on the market for neuropathic pain associated with DPN.
"Our New Drug Application for pregabalin is supported by clinical studies
involving more than 10,000 patients. In the area of neuropathic pain where
current treatment options are limited, pregabalin's clinical program
represents the largest and most robust undertaken to date," said Dr. John
LaMattina, president of Pfizer Global Research and Development. "Our
submission for pregabalin is another important step in fulfilling our goal
of filing 20 major NDAs in the five-year period ending in 2006." Earlier
this year, Pfizer filed with European regulatory authorities to seek
approval for the use of pregabalin in the treatment of neuropathic pain and
as an adjunctive therapy for partial seizures.
Source: Pfizer Inc
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Pfizer, Inc.
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World Headquarters
in New York, NY
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Over 120,000
employees worldwide
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2002 Revenue: $32.4
Billion
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2003 Research and
Development Budget: $7.1B
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Mission Statement:
We will become the world's most valued company to patients, customers,
colleagues, investors, business partners, and the communities where we work
and live.
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Purpose Statement:
We dedicate ourselves to humanity's quest for longer, healthier, happier
lives through innovation in pharmaceutical, consumer, and animal health
products.
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Products include:
Celebrex, Neurontin, Zoloft, Sudafed, Benadryl, Neosporin
Source: Pfizer
web site
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