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FDA GIVES TENTATIVE APPROVAL FOR GENERIC VERSION OF PROZAC.

IVAX Corporation (AMEX:IVX), Miami, Fla., has announced that the United States Food and Drug Administration (FDA) has given tentative approval to the company's ANDA for fluoxetine hydrochloride capsules in strengths of 10 mg and 20 mg. Fluoxetine hydrochloride is the generic equivalent of Prozac, marketed by Eli Lilly to treat depression, obsessive- compulsive disorder, and bulimia. It is believed that U.S. sales of Prozac(R) exceeded $2.2 billion in 1998. Fluoxetine hydrochloride will be marketed by IVAX's wholly-owned subsidiary, Zenith Goldline Pharmaceuticals, Inc. The anticipated launch date for the product is August 2001.

"The FDA's tentative approval of our generic fluoxetine hydrochloride is significant because Prozac(R) is one of the most popular drugs in the United States. The market for this product is substantial, and we intend to establish an early and strong presence among the companies providing a generic version of the drug," said Dr. Rafick Henein, president and chief executive officer of Zenith Goldline Pharmaceuticals. "We are extremely pleased to note that our research and development efforts this year have resulted in two final approvals and five tentative ones, with 19 ANDA's pending at the FDA. Further, we anticipate filing additional ANDA's before year's end."

IVAX Corporation, headquartered in Miami, Florida, is a holding company with subsidiaries engaged in the research, development, manufacture and marketing of branded and generic pharmaceuticals and veterinary and diagnostic products in the U.S. and international markets.

For more information, call 305/575-6043.
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Comment:FDA GIVES TENTATIVE APPROVAL FOR GENERIC VERSION OF PROZAC.
Publication:Biotech Business
Geographic Code:1USA
Date:Dec 1, 1999
Words:244
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