Prescription Drug Products; Digoxin Elixir; Extension to Obtain Marketing Approval

Resumen

The Food and Drug Administration (FDA) is announcing that it will continue to exercise enforcement discretion to assure the continued availability of digoxin elixirs after June 28, 2004, allowing manufacturers to continue to market these products without approved applications until December 28, 2004. FDA is granting this extension to give manufacturers of digoxin elixir additional time to obtain marketing approval and bring products to market.