U.S. Food and Drug Administration (FDA) Denies Abbott's Citizen Petition Regarding Levothyroxine Sodium Products - Company Confirms Previously Announced EPS Guidance for 2004 - ABBOTT PARK, Ill., June 23 /PRNewswire-FirstCall/ -- Abbott Laboratories was informed today by the U.S. Food and Drug Administration (FDA) that it has denied the Citizen Petition that Abbott filed at the FDA's request in August 2003 regarding bioequivalence of levothyroxine sodium products. SYNTHROID(R) (levothyroxine sodium tablets, USP), Abbott's thyroid medication, is now subject to generic competition. SYNTHROID is the second-most-prescribed drug in the United States. "Millions of patients and their physicians have relied on SYNTHROID as a trusted therapy for a half century," said Jeffrey M. Leiden, M.D., Ph.D., president and chief operating officer, Pharmaceutical Products Group, Abbott Laboratories. "SYNTHROID is also one of the least expensive medications -- branded or generic -- on the market today. Abbott is committed to continuing to make SYNTHROID available to patients." The relative cost for SYNTHROID is remarkably low. For example, the cost of the most common daily SYNTHROID strength (100mcg) is only approximately 70 cents at retail. Additionally, SYNTHROID is available for low-income seniors and other eligible Medicare beneficiaries for $5 per monthly prescription through Abbott's expanded Medicare Assistance Program. Abbott Confirms Previously Announced EPS Guidance for 2004 The company is confirming its previously announced guidance for earnings-per-share from continuing operations, excluding one-time charges, of $2.24 to $2.31 for the full year 2004, and for the second quarter of $0.53 to $0.55. These guidance ranges incorporate the possible impact of generic competition on SYNTHROID sales. Abbott anticipates one-time charges for the Hospira spin-off and acquisitions related to earnings-per-share from continuing operations of approximately $0.22 per share for the full-year, and $0.13 per share for the second quarter. Abbott notes that in accordance with Securities and Exchange Commission (SEC) Regulation G, projected earnings-per-share from continuing operations under Generally Accepted Accounting Principles (GAAP) would be $2.02 to $2.09 for the full year, and $0.40 to $0.42 for the second quarter. SYNTHROID(R) Indication and Safety Information SYNTHROID is indicated as replacement or supplemental therapy for primary, secondary, tertiary and subclinical hypothyroidism. SYNTHROID is not indicated for transient hypothyroidism during recovery of subacute thyroiditis. Thyroid hormones, including SYNTHROID, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects. Levothyroxine is contraindicated in patients with untreated subclinical or overt thyrotoxicosis, acute myocardial infarction, uncorrected adrenal insufficiency, or with hypersensitivity to any of the inactive tablet ingredients. Levothyroxine should not be used in the treatment of male or female infertility unless this condition is associated with hypothyroidism. Use with caution in patients with underlying cardiovascular disease. Adverse reactions associated with levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdosage. If a patient experiences any unusual symptoms, a healthcare provider should be contacted. The thyroid, a butterfly-shaped gland located in the neck just below the Adam's apple and above the collarbone, produces hormones that influence essentially every organ, tissue and cell in the body. Thyroid disease affects an estimated 13 million Americans, but approximately half do not know they have the condition. Women are five times more likely than men to develop hypothyroidism. Further information, including SYNTHROID full prescribing information, is available at http://www.synthroid.com/ or by calling 1 (800) 255-5162. About Abbott Laboratories Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/. Private Securities Litigation Reform Act of 1995 - A Caution Concerning Forward-Looking Statements Some statements in this news release may be forward-looking statements for the purposes of the Private Securities Litigation Reform Act of 1995. We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Exhibit 99.1 of our 2003 Annual Report on Securities and Exchange Commission Form 10-K, and are incorporated by reference. We undertake no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments. DATASOURCE: Abbott Laboratories CONTACT: Media: Catherine Bryan, +1-847-938-8551, or cell, +1-312-209-0250, or Laureen Cassidy, +1-847-938-7743, or cell, +1-847-772-1987, Jennifer Smoter, +1-847-935-8865, or Financial Community: John Thomas, +1-847-938-2655, or Larry Peepo, +1-847-935-6722, all of Abbott Laboratories Web site: http://www.abbott.com/ http://www.synthroid.com/ Company News On-Call: http://www.prnewswire.com/comp/110328.html

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