Abbott Laboratories' SYNTHROID(R) (Levothyroxine Sodium Tablets, USP) Confirmed Safe And Effective Through FDA Approval

Market Wire, 20050229

Abbott Laboratories announced today it received U.S. Food and Drug Administration (FDA) approval of its synthetic thyroid hormone replacement therapy, SYNTHROID(R) (levothyroxine sodium tablets, USP), for thyroid disease management, as replacement or supplemental therapy for hypothyroidism (underactive thyroid) and pituitary thyroid stimulating hormone suppression. Millions of patients and their physicians have relied on SYNTHROID for decades to maintain their thyroid health. Formal approval by FDA of SYNTHROID validates its safety and efficacy. With FDA approval, Abbott is now free to meet full market demand.

"Today's FDA approval is good news for the millions of Americans who rely on SYNTHROID every day to control their thyroid disease," said Jeffrey Leiden, M.D., Ph.D., Abbott's chief scientific officer and president, Global Pharmaceuticals. "This approval confirms what Abbott has known all along, that SYNTHROID is safe and effective. SYNTHROID is the same drug, and patients should continue to take their medication as they always have."

SYNTHROID is the number one prescribed treatment for hypothyroidism and the second most-prescribed medication overall in the United States. It is the most-studied levothyroxine sodium product, the subject of hundreds of clinical studies and featured in articles in prominent peer-reviewed medical journals. Major medical societies and patient-focused organizations -- including the American Association of Clinical Endocrinologists, the Endocrine Society, the American Thyroid Association, the Thyroid Foundation of America, and the Thyroid Cancer Survivors' Association -- publicly supported the continued use of SYNTHROID for the millions of patients on the medication during the FDA's review. Their support reinforces the importance of this product to patients.

"Today's FDA approval ensures that patients will continue to have access to this vital medication, which has been relied upon by physicians and patients for almost 50 years," said Paul Ladenson, M.D., director of the Division of Endocrinology and Metabolism at Johns Hopkins Medical Institutions.

"The approval of SYNTHROID is an important milestone in Abbott's commitment to patients and thyroid disease," said Dr. Leiden. "Abbott continues to conduct research to bring new and better treatment options to market."

Levothyroxine Products Are Not Therapeutically Equivalent to SYNTHROID

The FDA publication, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), does not list any levothyroxine sodium products as therapeutically interchangeable with SYNTHROID. Switching SYNTHROID patients to another brand of thyroid medication would require testing and retitration, if necessary. AACE guidelines recommend that patients who are switched must be retested and retitrated, which would be costly, time consuming, and potentially disruptive to patients.

SYNTHROID Approved as Safe and Effective

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 www.SYNTHROID.com or by calling 1 (800) 255-5162.

Abbott Laboratories is a global, broad-based 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.