Digoxin Products for Oral Use; Reaffirmation of New Drug Status and Conditions for Marketing

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The Food and Drug Administration (FDA) is reaffirming its determination that digoxin products for oral use (tablets and elixir) are new drugs and announcing the conditions for marketing the products. Manufacturers who wish to begin to market or to continue marketing digoxin products for oral use must submit new drug applications (NDA's) or abbreviated new drug applications (ANDA's). Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to revoke the regulations that establishes conditions for marketing digoxin products for oral use.