June 7, 2001

SOURCE: Abbott Laboratories

ABBOTT PARK, Ill., June 12 -- Abbott Laboratories today announced that it has filed suit against Watson Pharmaceuticals, Inc., Corona, Calif., seeking a Federal court injunction to immediately stop Watson's false advertising and deceptive trade practices regarding Abbott's prescription thyroid drug Synthroid® (levothyroxine sodium, USP). The suit also asks the court to order Watson to undertake an advertising campaign to correct the deliberate misinformation it has created within the medical community.

Abbott is taking this action to ensure patient safety and put an end to the fears, concerns and confusion that are being created among the more than eight million thyroid patients who depend on Synthroid everyday to successfully treat their thyroid disease.

``Abbott had no choice but to take this action to protect patients who have been inundated with alarming, medically-inaccurate information,'' said David Pizzuti, M.D., Abbott's Vice President, Global Medical Affairs. ``Synthroid has been used safely and effectively by millions of patients for decades and it is false and misleading for Watson to claim otherwise. Worse, are Watson's false assertions that Synthroid will be unavailable in the near future to the millions of patients who depend on it.''

Synthroid is a trusted therapy and accounts for more than 60 percent of prescriptions for thyroid replacement therapy. Major medical societies and patient-focused organizations, including the American Association of Clinical Endocrinologists, the American Thyroid Association, the Thyroid Foundation of America and the Thyroid Cancer Survivors' Association, have publicly stated support for keeping Synthroid available for the millions of patients who are currently well controlled on the medication.

Abbott will submit a New Drug Application (NDA) for Synthroid to meet the U.S. Food and Drug Administration's (FDA) filing requirements of August, 2001. Synthroid is the most studied form of levothyroxine sodium, with hundreds of clinical studies and publications in prominent peer-reviewed medical journals.

In its suit, Abbott charges that Watson is attempting to achieve through an orchestrated campaign designed to concern and confuse patients -- including misrepresentation of the FDA's regulatory process -- what Watson has evidently concluded it cannot gain by promoting its product on its own merits. The suit was filed today in Chicago.

``It is particularly disturbing,'' Dr. Pizzuti said, ``that misleading information is being provided about the switching of prescription thyroid drugs. Guidelines of several of the leading endocrinology associations recommend that patients remain on their brand of levothyroxine sodium if they are well controlled; if their medication is switched, patients must be reevaluated and retested. Otherwise, the health of patients may be at risk. Switching prescription thyroid drugs is not as simple as merely matching dosage. Because of the medical implications of switching, it is extremely irresponsible for Watson to falsely generate concerns about the continued availability of Synthroid.''

Additionally, the FDA Publication, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), does not list any levothyroxine sodium product as therapeutically interchangeable.

Synthroid, which was introduced in 1955, was the first orally administered levothyroxine product. Today, it is the third most-prescribed drug in the United States. Its acceptance is based upon hundreds of scientific studies and articles, as well as its continued use by millions of patients over many decades.

In 1997, the FDA announced that every manufacturer of levothyroxine drug products, most of which had been on the market for many years, would be required to file -- as part of that agency's regulatory review process -- either an NDA, or a citizen petition showing that their products are not new drugs and therefore do not require an NDA.

Synthroid's manufacturer at the time, Knoll Pharmaceutical Company, which Abbott acquired in March 2001, exercised the citizen petition option because of Synthroid's long history and track record. On April 26, the FDA denied Knoll's petition. Abbott promptly responded to the FDA that the company would submit an NDA for Synthroid.

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.