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FDA extends digoxin elixir NDA deadline

Executive Summary

FDA extends deadline for companies to have an approved application for digoxin elixir from June 28 to Dec. 28. The extension was made because "it now appears that...there may not be any manufacturers prepared to market digoxin elixir under an approved application," a 1notice published in the June 29 Federal Register states. FDA set the original deadline in a final rule published June 28, 2002, which also required NDAs for digoxin tablets (2"The Pink Sheet" July 1, 2002, p. 12)...
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