04-14796. Prescription Drug Products; Digoxin Elixir; Extension to Obtain Marketing Approval

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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.

DATES:

The date by which manufacturers must obtain marketing approval is extended to December 28, 2004.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

In the Federal Register of June 26, 2002 (67 FR 42992), FDA published a final rule revoking § 310.500 (21 CFR 310.500), which established conditions for marketing digoxin products for oral use (tablets and elixir). The agency concluded that § 310.500 was no longer necessary because the products, which are new drugs, can be regulated under the approval process for new drug applications and abbreviated new drug applications as set forth in the Federal Food, Drug, and Cosmetic Act (the act). Previously, in the Federal Register of November 24, 2000 (65 FR 70573), we reaffirmed the new drug status of oral digoxin products and announced that these products required approved applications for marketing.

The June 26, 2002, final rule advised that manufacturers who were marketing digoxin elixir drug products on or before June 26, 2002, may continue to market their products until June 28, 2004.¹ The final rule stated that a manufacturer who marketed a digoxin elixir drug product without an approved application after that date would be subject to regulatory action.

We permitted this period of continued marketing because we regard digoxin elixir products as medically necessary and, therefore, wanted to allow sufficient time for manufacturers to conduct the required studies and to prepare and submit applications, as well as to allow the agency sufficient time to review these applications. It now appears that as of June 28, 2004, there may not be any manufacturers prepared to market digoxin elixir under an approved application. To assure the continued availability of digoxin elixirs after June 28, 2004, we have decided to extend for 6 months, until December 28, 2004, the date by which manufacturers must obtain marketing approval. This extension will only apply to manufacturers who have submitted applications to FDA and who continue to pursue approval of their applications with due diligence. We will reexamine the need for a continued exercise of enforcement discretion at the end of this 6-month period. In making this determination, we will consider whether there is an approved digoxin elixir product on the market and whether the manufacturer is capable of producing sufficient product to meet patient needs.

This notice is issued under sections 502 and 505 of the act (21 U.S.C. 352, 355)) and under authority delegated to the Associate Commissioner for Policy and Planning (21 CFR 5.20).

Dated: June 24, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

Footnotes

1.  After June 26, 2002, a new digoxin elixir drug product could not be introduced into the market unless we had approved an application for that product.