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FDA Rejects Watson's Hormonal Patch

California | SOUTHLAND FOCUS

November 02, 2000|Bloomberg News

Watson Pharmaceuticals Inc. said the Food and Drug Administration rejected its hormonal patch to treat menopause symptoms because of insufficient evidence of the treatment's safety and efficacy. Corona-based Watson shares fell $2.69, or 4.3%, to close at $59.88 on the NYSE. The company said it had received an FDA "non-approval" letter on its estradiol-progestin patch that said too few patients were enrolled in the product's final testing stage. Watson, which got the product through its TheraTech Inc. acquisition last year, said it will file an amendment to address FDA concerns and that approval wasn't expected before 2002.

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