[Federal Register Volume 64, Number 111 (Thursday, June 10, 1999)]
[Notices]
[Page 31280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14751]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-1149]
Draft Guidance for Industry on in Vivo Pharmacokinetics and
Bioavailability Studies and in Vitro Dissolution Testing for
Levothyroxine Sodium Tablets; 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availability of a draft guidance for industry entitled ``In Vivo
Pharmacokinetics and Bioavailability Studies and in Vitro Dissolution
Testing for Levothyroxine Sodium Tablets.'' The draft guidance contains
agency recommendations on how to design in vivo pharmacokinetics and
bioavailability studies and perform in vitro dissolution testing for
levothyroxine sodium tablets.
DATES: Written comments on the draft guidance may be submitted by
August 9, 1999. General comments on documents are welcome at any time.
ADDRESSES: Copies of this draft guidance for industry can be obtained
on the Internet at ``http://www.fda.gov/cder/guidance/index.htm''.
Submit written requests for single copies of the draft guidance to the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 Submit written comments on the draft
guidance to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Comments and requests are to be identified with the docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Michael J. Fossler, Center for Drug
Evaluation and Research (HFD-870), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-6417.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance for industry entitled ``In Vivo Pharmacokinetics and
Bioavailability Studies and in Vitro Dissolution Testing for
Levothyroxine Sodium Tablets.'' This draft guidance contains agency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
43536).
Levothyroxine sodium was introduced into interstate commerce during
the 1950's without approval of new drug applications (NDA's) for the
drug products. As a result of concerns about the stability and
consistent potency of the products, the agency announced that orally
administered drug products containing levothyroxine sodium were new
drugs (62 FR 43536). The notice stated that a manufacturer who wished
to continue to market orally administered levothyroxine sodium products
had to submit an NDA. The agency allowed current manufacturers 3 years
to obtain approved NDA's, until August 14, 2000.
A number of firms have contacted FDA for advice regarding how to
conduct bioavailability studies and in vitro dissolution testing for
levothyroxine sodium tablets. Because of this interest, and the need to
provide consistent advice to all firms who intend to submit NDA's for
this product, FDA has developed this draft guidance on designing in
vivo pharmacokinetics and bioavailability studies and performing in
vitro dissolution testing for levothyroxine sodium tablets. The
guidance documents FDA's current thinking on this subject. Although the
guidance is being submitted in draft for comment, FDA recognizes that
sponsors of already marketed levothyroxine sodium products that are
required to obtain approved NDA's by August 14, 2000, may already have
begun to conduct bioavailability and dissolution studies. The study
design described in this guidance may be used for these studies or an
alternative approach may be used. In either case, the study designs
will be acceptable if scientifically justified. FDA will revise the
study designs described in the guidance in accordance with any comments
received, if appropriate.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices (62 FR 8961, February 27, 1997). The draft
guidance represents the agency's current thinking on in vivo
pharmacokinetics 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, regulations, or both.
Interested persons may, on or before August 9, 1999, submit to the
Dockets Management Branch (address above) written comments on the draft
guidance. 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
draft guidance and received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 3, 1999.
Peggy Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-14751 Filed 6-9-99; 8:45 am]
BILLING CODE 4160-01-F
