ZANTAC GASTRIC ULCER INDICATION APPROVED TWO YEARS AFTER FDA
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.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth