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Tagamet GERD indication

Executive Summary

SmithKline Beecham will begin marketing Tagamet (cimetidine) for treatment of erosive gastroesophageal reflux disease (GERD) diagnosed by endoscopy in late May, following receipt of FDA approval March 7. Glaxo's Zantac and Robins' Reglan already are approved for GERD. FDA approved Tagamet tablet, liquid and injection forms for "healing of lesions and control of symptoms." The Gastrointestinal Drugs Advisory Committee approval recommendation last October came 14 years after SB's initial NDA filing in 1976 ("The Pink Sheet" Oct. 29, p. 12).
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PS019130

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