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ZANTAC GASTRIC ULCER INDICATION APPROVED TWO YEARS AFTER FDA

Executive Summary

ZANTAC GASTRIC ULCER INDICATION APPROVED TWO YEARS AFTER FDA approval of Glaxo's original application for treatment of duodenaI ulcer in July 1983. New labeIing for the drug states that Zantac (ranitidine) is indicated in "short-term treatment of active, benign gastric ulcer." It adds that "most patients heal within six weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than six weeks." Glaxo cleared the second indication for Zantac June 28, in less than half the time it took SmithKline to get the gastric ulcer claim after Tagamet was approved in 1977 for the treatment of duodenaI ulcer. Tagamet received a gastric ulcer indication on Dec. 30, 1982. Tagamet still carries one indication that Zantac does not; cimetidine is indicated for prophylactic use in duodenal ulcer patients "to prevent ulcer recurrence in patients likely to need surgical treatment." Glaxo is also pursuing that indication.

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