FDA GIVES TENTATIVE APPROVAL FOR GENERIC VERSION OF PROZAC.
"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.|
|Date:||Dec 1, 1999|
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