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  10Jul2000 USA: Technology Journal - Premenstrual Use Of Prozac Approved By U.S. Officials.

WASHINGTON - The U.S. government approved Prozac as the first drug treatment for severe mood problems experienced by some women before their menstrual periods.

The antidepressant, made by Eli Lilly & Co., Indianapolis, will be marketed for the new indication under the brand name Sarafem.

The Food and Drug Administration approved it for treatment of premenstrual dysphoric disorder, or PMDD, a condition consisting of mood changes and physical symptoms that are severe enough to interfere with a woman's ability to function.

The FDA noted the difference between PMDD, which is estimated to affect about 3% to 5% of women, and minor mood changes and physical pains commonly referred to as premenstrual syndrome, or PMS.

Women affected by PMDD "miss work, they miss school, they have increased interpersonal problems and domestic problems," said Thomas Laughren, leader of the FDA's psychiatric-drug team. "This is not typical PMS."

Physicians have already been prescribing Prozac and other antidepressants for premenstrual mood problems. Analysts don't expect the new indication to make a significant impact on Prozac sales.

(Copyright (c) 2000, Dow Jones & Company, Inc.).

Source: WALL STREET JOURNAL EUROPE 10/07/2000



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