[Federal Register Volume 65, Number 81 (Wednesday, April 26, 2000)]
[Notices]
[Pages 24488-24489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10322]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0314]


Prescription Drug Products; Levothyroxine Sodium; Extension of 
Compliance Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of compliance date.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
manufacturers who were marketing orally administered drug products 
containing levothyroxine sodium on or before August 14, 1997, may 
continue to market these products without approved applications until 
August 14, 2001. FDA is extending by 1 year the compliance date given 
in the notice published in the Federal Register of August 14, 1997 (62 
FR 43535). The agency is taking this action to give manufacturers 
additional

[[Page 24489]]

time to conduct studies and to prepare applications.

EFFECTIVE DATE: April 26, 2000.

FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, 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 August 14, 1997 
(62 FR 43535), FDA announced that orally administered drug products 
containing levothyroxine sodium are new drugs and required 
manufacturers to have approved applications as a condition of 
marketing. The notice advised that manufacturers who were marketing 
levothyroxine sodium drug products on or before August 14, 1997, may 
continue to market their products until August 14, 2000.\1\ The notice 
stated that a manufacturer who marketed a levothyroxine sodium drug 
product without an approved application after that date would be 
subject to regulatory action.
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    \1\ After August 14, 1997, a new levothyroxine drug product may 
not be introduced into the market unless FDA has approved an 
application for that product.
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    FDA permitted this period of continued marketing because it regards 
levothyroxine sodium 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. FDA has 
now concluded that manufacturers may need additional time to conduct 
studies and to prepare applications. Therefore, the agency extends by 1 
year the compliance date given in the Federal Register notice of August 
14, 1997, to permit continued marketing of these products until August 
14, 2001.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 502, 505 (21 U.S.C. 352, 355)) and under authority delegated 
to the Associate Commissioner for Regulatory Affairs (21 CFR 5.20).

    Dated: April 18, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-10322 Filed 4-25-00; 8:45 am]
BILLING CODE 4160-01-F