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In Brief: Block Drug's amlexanox

Executive Summary

Block Drug's amlexanox: "Approvable" at FDA for the treatment of signs and symptoms of aphthous ulcers (canker sores) as of April 16. Amlexanox will be the first product marketed for canker sores. The NDA was filed April 17, 1995; a first NDA was filed in September 1994 but was refused because of inspection access issues. Drug codeveloper Access Pharmaceuticals of Dallas sold its rights to amlexanox in September...
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