[Federal Register: June 29, 2004 (Volume 69, Number 124)]
[Page 38906]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket Nos. 1976N-0080 and 2000N-1610]

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 Sec.  310.500 (21 CFR 
310.500), which established conditions for marketing digoxin products 
for oral use (tablets and elixir). The agency concluded that Sec.  
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.

    \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.

    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.
[FR Doc. 04-14796 Filed 6-25-04; 2:57 pm]