In Brief: Wyeth-Ayerst's I.V. Cordarone
Executive Summary
Wyeth-Ayerst's I.V. Cordarone: Is "approvable" by FDA as of Feb. 10. The antiarrhythmic amiodirone injectable therapy was recommended for approval by an FDA advisory committee in October at which the differing pharmacokinetic profiles of the I.V. and marketed oral formulations was a major issue. The NDA for Cordarone I.V. was submitted in January 1993...