[Federal Register Volume 66, Number 46 (Thursday, March 8, 2001)]
[Notices]
[Pages 13935-13936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5610]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-1149]


Guidance for Industry on Levothyroxine Sodium Tablets--In Vivo 
Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution 
Testing; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Levothyroxine Sodium 
Tablets--In Vivo Pharmacokinetic and Bioavailability Studies and In 
Vitro

[[Page 13936]]

Dissolution Testing.'' This guidance is intended to assist sponsors of 
new drug applications (NDA's) for levothyroxine sodium tablets who wish 
to conduct in vivo pharmacokinetic and bioavailability studies and in 
vitro dissolution testing for their products.

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Drug Information Branch (HFD-210), Center for Drug Evaluation 
and Research, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857. Send one self-addressed adhesive label to assist 
that office in processing your requests. Submit written comments on the 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Mei-Ling Chen, Center for Drug 
Evaluation and Research (HFD-350), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5688.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Levothyroxine Sodium Tablets--In Vivo Pharmacokinetic and 
Bioavailability Studies and In Vitro Dissolution Testing.'' This 
guidance contains agency recommendations on how to design in vivo 
pharmacokinetics and bioavailability studies and perform in vitro 
dissolution testing for levothyroxine sodium tablets, which were 
identified as new drugs in a notice published in the Federal Register 
of August 14, 1997 (62 FR 43535).
    FDA announced the availability of a draft version of this guidance 
in the Federal Register of June 10, 1999 (64 FR 31280). The June 1999 
draft document gave interested persons 60 days to submit comments. FDA 
carefully considered the comments it received and has made appropriate 
revisions. A separate section on biowaiver has been added to clarify 
information that appeared elsewhere in the draft guidance. The guidance 
also specifies that plasma/serum profiles and pharmacokinetic measures 
should be presented without adjustment of baseline levels.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). 
The guidance represents the agency's current thinking on in vivo 
pharmacokinetic and bioavailability studies and in vitro dissolution 
testing for levothyroxine sodium tablets. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain this guidance at 
http://www.fda.gov/cder/guidance/index.htm.

    Dated: March 1, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-5610 Filed 3-7-01; 8:45 am]
BILLING CODE 4160-01-F