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Strategies & Market Trends : Booms, Busts, and Recoveries

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To: Louis V. Lambrecht who wrote (37318)8/19/2003 11:51:05 AM
From: Tadsamillionaire  Read Replies (1) of 74559
 
FDA to Forest: Stop Selling Thyroid Drug
Tuesday August 19, 10:23 am ET

WASHINGTON (Reuters) - The U.S. Food and Drug Administration (News - Websites) has sent a warning to Forest Laboratories Inc. (NYSE:FRX - News) for failing to obtain approval for thyroid drug Levothroid and told the company to stop marketing it, according to a letter released on Tuesday.
"You have failed to obtain an approved application and have made a deliberate decision not to follow the agency's gradual phase-out plan ...," the FDA wrote in a letter dated Aug. 7.

The letter was posted on the agency's Web site on Tuesday.

Thyroid drugs containing levothyroxine sodium were sold for years without FDA approval. In July 2001, the FDA told companies selling the drugs to submit applications for approval by August 14, 2003, while gradually phasing out production over two years.

Because Forest failed to do so, the FDA told the company to stop selling Levothroid. The letter requests a response within 15 days "stating the action you will take to discontinue the marketing of your Levothroid drug products."

A Forest spokesman could not immediately be reached for comment.

Forest shares fell 10 cents to $43.04 in morning trading on the New York Stock Exchange (News - Websites).

biz.yahoo.com
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