WASHINGTON (Reuters - August 11, 2000) - U.S. health officials said Friday Novartis AG's drug Zelmac was ``approvable'' for treating irritable bowel syndrome. A Food and Drug Administration (FDA) spokesman said the agency sent Novartis an approvable letter regarding Zelmac, a product the company bills as a future blockbuster.
Such letters typically mean the FDA finds the product generally acceptable, but wants to resolve certain issues with the manufacturer. ``We sent an approvable letter (on Zelmac),'' the FDA spokesman said.
An estimated 25 million Americans, most of them women, have irritable bowel syndrome, a disease that can cause debilitating symptoms. Novartis has asked the FDA to clear Zelmac for treating women with the disease whose main symptom is constipation. Copyright 2000, Reuters News Service
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