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BOTOX Cosmetic U.S. FDA Approval -- One Year Later.


Business Editors/Health/Medical Writers

IRVINE, Calif.--(BUSINESS WIRE)--April 30, 2003

One year after the approval by the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
), Allergan, Inc. (NYSE NYSE

See: New York Stock Exchange
:AGN AGN Again (Amateur Radio)
AGN Active Galactic Nucleus
AGN Acute Glomerulonephritis
AGN Accountants Global Network
AGN Air Gabon (ICAO code) 
) today said BOTOX(R) Cosmetic (botulinum toxin type A botulinum toxin type A

Botox, Botox Cosmetic, Dysport (UK), Vistabel (UK)

Pharmacologic class: Neurotoxin

Therapeutic class: Neuromuscular blocker

Pregnancy risk category C

Action

) ranks as the most successful launch in the Company's 53-year history and the second most recognizable pharmaceutical brand in the United States.

Although BOTOX(R) was first approved by the FDA in 1989, clinical trial investigations began over 20 years ago. BOTOX(R) has now been approved in over 70 countries for a variety of uses, with millions of people worldwide having benefited from BOTOX(R) treatments. In all, the BOTOX(R) product has been used safely and effectively in over 7 million treatments for approximately 2 1/2 million people since its first approval in the U.S. The FDA approved BOTOX(R) Cosmetic on April 12, 2002 specifically for the temporary improvement of frown lines in adult patients. The FDA approval of BOTOX(R) Cosmetic immediately ignited worldwide news coverage. Highlights in the first year of launch included:

-- Cosmetic use is now approved in 21 countries under the names

BOTOX(R), BOTOX(R) Cosmetic and VISTABEL(R);

-- More than 500,000 men and women were treated with BOTOX(R)

Cosmetic in 2002, making it the #1 cosmetic treatment in

America;

-- More than 10 million men and women were identified to be

potential candidates for BOTOX(R) Cosmetic treatments (Gallup

Facial Appearance Improvement Survey, 2002);

-- More than 7,000 broadcast stories and 6,500 articles on

BOTOX(R)/BOTOX(R) Cosmetic were done in the U.S.;

-- Approximately 4,500 aesthetic-specialty physicians were

registered on the BOTOX(R) Cosmetic Physicians' Network,

providing BOTOX(R) Cosmetic treatments to residents of all 50

states; and

-- Over 600,000 searches for BOTOX(R) Cosmetic physicians were

performed on www.botoxcosmetic.com.

BOTOX(R) Cosmetic is approved and marketed specifically for temporary improvement of frown lines in men and women aged 18 to 65. It's a natural, purified protein, which in very low doses relaxes the overactive o·ver·ac·tive  
adj.
Active to an excessive or abnormal degree: an overactive child.



o
 muscles that cause frown lines to form. The effects last about four months, after which lines gradually revert to their pre-treatment appearance. The most common side effects Side effects

Effects of a proposed project on other parts of the firm.
 of BOTOX(R) Cosmetic, if any occur, may include headache, respiratory infection, flu syndrome, temporary eyelid eyelid /eye·lid/ (-lid) either of two movable folds (upper and lower) protecting the anterior surface of the eyeball.

eye·lid or eye-lid
n.
 droop and nausea. For more information, please see www.botoxcosmetic.com.

BOTOX(R) is approved and marketed in the United States for painful abnormal head and neck position (cervical dystonia cervical dystonia Spasmodic torticollis, see there ), crossed eyes crossed eyes
n.
See esotropia.
 (strabismus strabismus (strəbĭz`məs), inability of the eyes to focus together because of an imbalance in the muscles that control eye movement; also called squint. ) and uncontrollable blinking (blepharospasm bleph·a·ro·spasm
n.
Spasmodic winking caused by the involuntary contraction of an eyelid muscle.



blepharospasm

spasm of the orbicularis oculi muscle of the eyelid.
), and is currently being investigated for the treatment of severe headache, excessive sweating and upper limb spasticity spasticity /spas·tic·i·ty/ (spas-tis´i-te) the state of being spastic; see spastic (2).

spas·tic·i·ty
n.
1. A spastic state or condition.

2. Spastic paralysis.
. For these and other potential uses for BOTOX(R) therapy, Allergan has invested more than $175 million in research and development over the past three years alone. Medical pioneers the world over are developing a myriad of possible new uses for a broad spectrum of under-treated or poorly managed conditions, potentially sparing patients difficult surgeries or hard-to-tolerate oral drugs. For more information about BOTOX(R), please visit www.botox.com.

Forward-Looking Statements

Any of the above statements that refer to Allergan's estimated or anticipated future results are forward-looking and reflect Allergan's current analysis of existing trends and information. Actual results may differ from current expectations based on a number of factors affecting Allergan's businesses, including, among other things, the inherent uncertainties associated with the research and development process and the regulatory approval process, technological advances and patents attained by competitors, general competitive conditions and changing market conditions, including changing consumer preferences and the performance and acceptance of new products. These forward-looking statements represent Allergan's judgment only as of the date of this press release. Actual results could differ materially from those projected in this press release. As a result, the reader is cautioned not to rely on these forward-looking statements. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Additional information concerning these and other risk factors can be found in press releases issued by Allergan as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Certain Factors and Trends Affecting Allergan and its Businesses" in Allergan's Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2002. Copies of Allergan press releases and additional information about Allergan are available on the World Wide Web at www.allergan.com, or you can contact the Allergan Investor Relations Investor relations

The process by which the corporation communicates with its investors.
 Department by calling 714-246-4636.

About Allergan, Inc.

Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing eye care and specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator and skin care markets that deliver value to our customers, satisfy unmet medical needs, and improve patients' lives.
COPYRIGHT 2003 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Apr 30, 2003
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