Allergan Comments On FDA Untitled Letter.Business Editors & Health/Medical Writers IRVINE, Calif.--(BUSINESS WIRE)--Sept. 12, 2002 Allergan (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 commented on the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. Food and Drug Administration's (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. ) untitled letter dated September 5, 2002 regarding certain BOTOX(R) Cosmetic marketing material. In the September 5 letter, the FDA has raised concerns with a portion of Allergan's promotional material for BOTOX(R) Cosmetic. Allergan is currently engaged in preliminary discussions with the FDA and intends to respond to the untitled letter by September 16, 2002. "In recent media accounts, the impression has been given that Allergan intends to 'take on the FDA' over the September 5 letter. This is incorrect. Allergan has the highest regard for the FDA and for its division, the Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, which is in the United States Department of Health and Human Services. (CBER CB·er n. One that uses a CB radio. ), with which Allergan has worked productively for many years," explained David E.I. Pyott, Allergan's Chairman of the Board, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "CBER has been very reasonable in its review of Allergan's marketing material for BOTOX(R) Cosmetic and I have no reason to believe they will be anything but reasonable here. CBER has raised some concerns about some of our material, which is their right as it is our right to provide a detailed written response for their review. I am quite confident that we will be able to address CBER's concerns to their complete satisfaction, as we have always done in the past." It would be premature for Allergan to make any decision about the untitled letter without providing the FDA with a response and engaging in a meaningful discussion with the FDA. This is the normal process after a routine review and comment by the FDA on promotional items. If, after discussions with the FDA, changes to marketing material are ultimately required, Allergan will of course make those changes. Forward-Looking Statements Any statements in this press release that refer to anticipated future events are forward-looking statements. All forward-looking statements in this press release reflect Allergan's current analysis of existing trends and information and represent Allergan's judgment only as of the date of this press release. Actual results may differ from current expectations based on a number of factors affecting Allergan's businesses. Therefore, the reader is cautioned not to rely on these forward-looking statements. Allergan expressly disclaims 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 2001 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. , and Allergan's Form 10-Q Form 10-Q See 10-Q. for the quarter ended June 28, 2002. Copies of Allergan press releases and additional information about Allergan is 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. |
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