Bristol Signals Dapaglifozin’s Back On Track, Plans FDA Resubmission
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Bristol suggests FDA has had a change of heart on the evolving filing package for diabetes drug dapagliflozin. Meanwhile, the company sees no additional U.S. regulatory hurdles ahead for the eagerly awaited, novel oral anticoagulant Eliquis.
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