June 1, 2001

SOURCE: Abbott

Abbott Park, Illinois, June 1, 2001 - Abbott is aware of the news reports circulating today regarding Synthroid®. Abbott wants to reassure patients, physicians and pharmacists that Synthroid is a safe and effective treatment for hypothyroidism. Abbott will be submitting a New Drug Application (NDA) in accordance with FDA guidelines in order to ensure that the eight million patients effectively treated with Synthroid have continued access to their medication. Abbott has notified the FDA of its intent to submit its NDA and is working cooperatively with the agency to meet the filing timeframes.

Like some other drugs that were marketed before 1962, Synthroid and all other levothyroxine sodium products did not receive formal approval from FDA. In 1997, FDA issued a Federal Register notice calling for all manufacturers of levothyroxine sodium products to either submit an NDA, or to file a citizen petition to show that their products are not new drugs, and therefore do not require an NDA. In compliance with this notice, Knoll, the manufacturer of Synthroid at the time, filed a citizen petition in 1997 requesting that FDA acknowledge that Synthroid could be given a legal designation, "generally recognized as safe and effective," (GRAS/E).

Abbott obtained Synthroid on March 2, 2001, through its acquisition of BASF Pharma/Knoll. On April 27, 2001 FDA informed Abbott that it would not grant GRAS/E status for Synthroid under Knoll's citizen petition. Abbott Laboratories promptly responded that it would submit an NDA for Synthroid.

Synthroid is the leading levothyroxine sodium product that has been trusted by physicians and patients for 42 years. The safety and efficacy of Synthroid has been extensively studied and validated. The results of these studies have been published in prominent peer-reviewed journals such as the New England Journal of Medicine. The place of Synthroid in clinical practice is well established as a trusted therapy by physicians, and by the more than eight million patients with hypothyroidism depend on it every day.

"Synthroid is a tried and trusted product with decades of use and physicians and patients should continue to have confidence in Synthroid," said Leonard Wartofsky, M.D., chairman, Department of Medicine, Washington Hospital Center, Washington, D.C. "It would be dangerous for patients if Synthroid were removed from the market."

Physicians and patients should understand that FDA has not made a determination that any levothyroxine sodium product, on the market with or without NDAs, are interchangeable with another. Therefore, these products have not been determined to be therapeutically equivalent by FDA. The FDA publication, Approved Drug Products with Therapeutic Equivalence Evaluations, does not list any levothyroxine sodium products as therapeutically interchangeable. Switching from Synthroid to another levothyroxine sodium product would require individual titration by a physician.

As part of the delicate endocrine system, the thyroid gland impacts essentially every cell, tissue and organ in the body. Guidelines of several endocrinology organizations, such as the American Association of Clinical Endocrinologists (AACE), state that, once stabilized, thyroid patients should be maintained on the same brand of medication throughout treatment. If changes in the medication brand are made, costly re-testing must occur to ensure proper dose adjustment treatment.

Thyroid hormones, either alone or together with other medicines, should not be used for the treatment of obesity, and should not be taken by patients with untreated thyrotoxicosis (excess of thyroid hormone), uncorrected adrenal insufficiency, or apparent hypersensitivity to thyroid hormones or any inactive product constituents. Adverse events to Synthroid other than those related to thyrotoxicosis as a result of overdosage are rare; however, if a patient experiences any unusual symptoms, he or she should consult with their health care provider.

Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries.