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Biotech / Medical : Eli Lilly
LLY 1,071+0.1%10:12 AM EST

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To: Anthony Wong who wrote (356)10/7/1998 11:04:00 AM
From: Anthony Wong  Read Replies (1) of 642
 
Lilly drug denied for new use, stock falls
Wednesday October 7, 10:40 am Eastern Time

CHICAGO, Oct 7 (Reuters) - Shares of pharmaceutical giant Eli
Lilly and Co. fell on Wednesday after regulators denied approval for an additional use of its drug Zyprexa currently marketed for the treatment of schizophrenia.

Lilly said it received a non-approvable letter from the U.S. Food and Drug Administration for use of Zyprexa to treat manic depression or bipolar disorders.

The FDA's action was a surprise to analysts who had expected regulatory approval for marketing the drug in the current quarter.

''The product is out and there is lots of data out on its safety and efficacy,'' said Neil Sweig, pharmaceutical industry analyst at Southeast Research Partners. ''I don't know what has been requested but, be assured, this is the highest priority for Lilly and Lilly will do whatever is necessary to get it approved,'' he said.

Lilly said it plans to work with the FDA to resolve the issues in the application.

Shares of Lilly were trading off 2-3/4 to 74-3/4 on turnover of about 1.7 million shares. Trading in Lilly shares had been delayed at the opening due to an imbalance of orders.

biz.yahoo.com
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