[Federal Register Volume 63, Number 94 (Friday, May 15, 1998)]
[Notices]
[Page 27092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12903]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0287]


Guidance for Industry on Buspirone Hydrochloride Tablets In Vivo 
Bioequivalence 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 ``Buspirone 
Hydrochloride Tablets In Vivo Bioequivalence and In Vitro Dissolution 
Testing.'' This is revision 1 of the guidance. The guidance has been 
revised to reflect the recent availability of buspirone hydrochloride 
tablets in 15-milligram dosage forms. Bioequivalence is tested using 
the highest available dosage of the reference listed drug. The revised 
guidance also notes the nonlinearity of buspirone at multiple-dosing.

DATES: Written comments on agency guidance documents may be submitted 
at any time.

ADDRESSES: Copies of this guidance for industry are available on the 
Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Submit 
written requests for single copies of ``Buspirone Hydrochloride Tablets 
In Vivo Bioequivalence and In Vitro Dissolution Testing'' 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 this guidance to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Sikta Pradhan, Center for Drug 
Evaluation and Research (HFD-652), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5847.

SUPPLEMENTARY INFORMATION: This guidance document is a level 2 guidance 
document consistent with FDA's good guidance practices (62 FR 8961, 
February 27, 1997). It represents the agency's current thinking on 
buspirone hydrochloride tablets in vivo bioequivalence and in vitro 
dissolution testing. 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 
requirement of the applicable statute, regulations, or both.
    Interested persons may submit written comments on the guidance at 
any time 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

    Dated: May 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-12903 Filed 5-14-98; 8:45 am]
BILLING CODE 4160-01-F