[Federal Register Volume 64, Number 247 (Monday, December 27, 1999)]
[Notices]
[Pages 72355-72356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33396]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-4461]


Withdrawal of Guidance Document on Selegiline Hydrochloride 
Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing a 
guidance for industry entitled ``Selegiline Hydrochloride Tablets: In 
Vivo Bioequivalence and In Vitro Dissolution Testing.'' This guidance, 
which was issued in December 1995, is being withdrawn because it does 
not represent current agency thinking on in vivo bioequivalence (BE) 
and in vitro testing for selegiline hydrochloride.

DATES: General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written comments on agency guidance documents to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Aida L. Sanchez, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-857-5847.

SUPPLEMENTARY INFORMATION: FDA is withdrawing a guidance for industry 
entitled ``Selegiline Hydrochloride Tablets: In Vivo Bioequivalence and 
In Vitro Dissolution Testing.'' This guidance addresses BE and 
dissolution testing for selegiline. This guidance is being withdrawn 
because it does not include the appropriate acceptance criteria for 
parent selegiline in plasma. Based on a new understanding of the 
pharmacokinetics of selegiline hydrochloride developed since the 
publication of the selegiline guidance, FDA has been requesting 
applicants to demonstrate that the point estimate of the test to 
reference ratio for area under plasma concentration-time curve (AUC) 
and peak blood plasma concentration (Cmax) of the parent falls within 
80 to 125 percent. These criteria have been used for the demonstration 
of bioequivalence of all selegiline tablets and capsules currently on 
the market. In addition, the guidance, which was issued in December 
1995, includes information only on selegiline tablets and not 
selegiline capsules, which have been approved by FDA since the issuance 
of the guidance to be withdrawn.
    The withdrawal of this guidance is part of a long-term effort in 
the Office of Generic Drugs (OGD) to review guidance documents on the 
development of generic drug products with the goal of identifying 
documents that need to be revised, reformatted, or withdrawn because 
they are no longer current (64 FR 36886, July 8, 1999). OGD hopes the 
guidance review process will result in guidances for industry that 
better reflect the current thinking of the agency on generic drug 
development and that will eliminate the need for drug-specific 
bioavailability (BA) and BE guidances. A guidance currently under 
development on BA and BE studies for orally administered drug products 
will serve as a core guidance on BA and BE once it has been finalized 
and will replace most product-specific guidances.
    The agency welcomes comments on its efforts to review existing 
guidances related to the development of drug products and revise, 
reformat, or withdraw them, as appropriate. This information is being 
issued consistent with FDA's good guidance practices (62 FR 8961, 
February 27, 1997). It does not create or confer any rights for or on 
any

[[Page 72356]]

person and does not operate to bind FDA or the public.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on agency guidance 
documents. 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. 
Received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 15, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-33396 Filed 12-23-99; 8:45 am]
BILLING CODE 4160-01-F