Pfizer's Eagerly Anticipated Impotence Drug Viagra Wins FDA Approval
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`Dow Jones Online News
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`March 27, 1998 Friday 6:09 PM GMT
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`Copyright 1998 Factiva, a Dow Jones and Reuters Company
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`All Rights Reserved
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`Copyright © 1998, Dow Jones & Company, Inc.)
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`Length: 576 words
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`Body
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`NEW YORK -(Dow Jones)- The Food and Drug Administration Friday announced approval of a long-awaited
`impotence drug, Pfizer Inc.'s Viagra, which is the first pill for the disorder.
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`With a potentially huge market, the drug is expected to become a big seller for Pfizer. Arvind Desai, an analyst who
`follows the company for OrbiMed Advisor, said sales could reach $1 billion the fifth year after launch.
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`Some analysts are even more optimistic, saying the drug could become a household name like the antidepressant
`Prozac and ring up sales of $2 billion or more annually. Last week, William C. Steere, Pfizer's chairman and chief
`executive, told The Wall Street Journal the drug may help Pfizer top Merck & Co. as the biggest seller of
`prescription medicines in the world.
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`The company said in the U.S. alone, 20 million to 30 million men suffer from some form of impotence.
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`But as with Prozac and the recent wave of diet drugs, there's a chance Viagra will find its way into the hands of a
`lot of people who don't need it medically but think it will make their sex lives better anyway. That possibility troubles
`medical ethicists.
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`Expected to hit the market around mid-April, the drug went through the FDA's application process in less than six
`months. The drug isn't approved anywhere else in the world.
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`Viagra doesn't work like other treatments, which can include injections, suppository-like devices or even surgery.
`Generically called sildenafil, the drug was first tested to fight angina, the painful heart condition caused by
`constricting or clogging of heart arteries. That didn't work, but the men in the study reported having better erections
`than before.
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`As an impotence drug, Viagra is taken an hour or so before a sexual event. Once a man's brain kicks into gear as
`he becomes aroused, Viagra works subtly to amplify the effects of erection-promoting chemicals in the penis.
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`In heart patients, sildenafil was supposed to treat angina and hypertension by blocking the action of an enzyme,
`phosphodiesterase, that is believed to tighten muscles lining blood-vessel walls. Researchers soon discovered that
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`Pfizer's Eagerly Anticipated Impotence Drug Viagra Wins FDA Approval
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`while the drug wasn't very good at thwarting the heart enzyme it homed in on a different form of the same enzyme
`that is present mainly in the penis.
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`Pfizer, which got the blessing of the Vatican for the drug because it can enhance marital relations, tried to dissuade
`people into thinking that Viagra is a "love drug" that will boost one's libido.
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`"Viagra works in response to sexual stimulation," said Joseph Feczko, M.D., Pfizer's senior vice president for
`medical and regulatory operations. "It has no properties of an aphrodisiac and does not stimulate fantasy."
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`Also, the FDA warned that it shouldn't be taken more than once a day. Some side effects include headache,
`flushing, indigestion and altered color perception.
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`Pfizer tested Viagra on 4,000 men. The drug was 70% effective across patients with impotence caused by
`diabetes, spinal cord injury or psychological causes, among others.
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`Patients are advised not to take the medication with organic nitrates, such as nitroglycerin patches or sublingual
`tablets, because the combination may lower blood pressure.
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`Pfizer said Viagra should be available with a prescription by mid-April at a wholesale price of $7 a tablet.
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`In composite New York Stock Exchange trading Friday, Pfizer shares (PFE) climbed $1.375 to $95.75 in active
`trading.
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`Copyright (c) 1998 Dow Jones & Company, Inc.
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`All Rights Reserved.
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`Notes
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`PUBLISHER: Dow Jones & Company
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`Classification
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`Language: ENGLISH
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`Publication-Type: Newswire
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`Journal Code: DJON
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`Subject: UROGENITAL DISORDERS & INJURIES (90%); SEXUAL DYSFUNCTION (90%); HEART DISEASE
`(89%); CARDIOVASCULAR DISEASE (89%); ENZYMES (86%); DRUG & MEDICAL DEVICES APPROVAL
`(78%); APPROVALS (78%); US FEDERAL GOVERNMENT (78%); US FDA APPROVALS (78%); US FDA
`REVIEW
`(78%); MEN
`(78%); DIETING
`(73%); RESEARCH REPORTS
`(71%); EXECUTIVES
`(69%);
`HYPERTENSION (68%); MEDICAL ETHICS (66%); RELIGION (60%); C13 Regulation/Government Policy; CCAT
`Corporate/Industrial News; M11 Equity Markets; MCAT Market News
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`Company: PFIZER INC (96%); MERCK & CO INC (91%); DOW JONES & CO INC (58%); WALL STREET
`JOURNAL (56%); PFIZ PFIZER INC (USA)
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`Organization: FOOD & DRUG ADMINISTRATION (94%)
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`Ticker: PFZ (LSE) (96%); PFE (NYSE) (96%); MRK (PAR) (91%); MRK (NYSE) (91%)
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`Industry: PHARMACEUTICALS
`(90%); PHARMACEUTICAL
`(90%); ANTIDEPRESSANTS
`INDUSTRY
`PREPARATION MFG (89%); CHEMICALS MFG (89%); DRUG & MEDICAL DEVICES APPROVAL (78%);
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`Pfizer's Eagerly Anticipated Impotence Drug Viagra Wins FDA Approval
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`ENZYME INHIBITORS (78%); US FDA APPROVALS (78%); US FDA REVIEW (78%); CENTRAL NERVOUS
`SYSTEM DRUGS (78%); PRESCRIPTION DRUGS (78%); WEIGHT LOSS DRUGS (73%); I257 Pharmaceuticals
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`Geographic: UNITED STATES (79%); NAMZ North American Countries; USA United States; USE Northeast U.S.;
`USNY United States - New York
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`FDA, NME, NY, US, USE
`DJI Codes: NCY, DRG, DFP, DHZ, DPH, DJS, WEI,
`DJI Descriptors: Consumer Non-Cyclical, Drug Manufacturers, Top Business Stories, Top Health-Care Stories for
`DJON, Pharmaceuticals, Dow Jones News Special Reports, Dow Jones Total Market Index, Food and Drug
`Administration (FDA) North America, New York, United States, Northeast U.S.
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`Load-Date: December 17, 2004
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`End of Document
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