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New Drug Application Submitted for Synthroid

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<P ALIGN="center"><B>New Drug Application Submitted for Synthroid</B></P>

August 8, 2001

New York - Abbott Laboratories has submitted a New Drug Application (NDA) for levothyroxine sodium (Synthroid) to the US Food and Drug Administration (FDA), in advance of the FDA's deadline of August 14.

"The submission of this NDA is an important milestone in Abbott's continuing commitment to the millions of thyroid patients who rely on Synthroid," said Jeffrey Leiden, MD, PhD, Abbott's chief scientific officer and executive vice president, Global Pharmaceuticals.

"The application we have submitted to the FDA includes safety and efficacy data from years of clinical use of Synthroid by millions of patients, and we are confident that the application will be approved," said David Pizzuti, MD, vice president, Global Medical Affairs.

Although the FDA has allowed Synthroid to remain on the market after August 14, 2001, while its NDA is pending, Abbott will be required to reduce gradually the drug's average monthly distribution as outlined in the FDA's guidance document.

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

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

Synthroid has been in use since 1955 and was the first orally administered levothyroxine sodium product. It is currently the most-prescribed drug for the treatment of hypothyroidism. Synthroid is the third most-prescribed drug overall in the United States.

The FDA's talk paper on the guidance for levothyroxine products is available at http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01089.html.

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