Bioequivalence Recommendations for Lamotrigine; Draft Guidance for Industry; Availability, 4916-4917 [2016-01683]


[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Pages 4916-4917]
From the Federal Register Online via the Government Publishing Office []
[FR Doc No: 2016-01683]

[[Page 4916]]



Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Bioequivalence Recommendations for Lamotrigine; Draft Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised draft guidance for industry on lamotrigine 
extended-release tablets entitled ``Draft Guidance on Lamotrigine.'' 
The recommendations provide specific guidance on the design of 
bioequivalence (BE) studies to support abbreviated new drug 
applications (ANDAs) for lamotrigine extended-release tablets.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 28, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic submissions in the following way:
     Federal eRulemaking Portal: 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2007-D-0369 for ``Draft Guidance on Lamotrigine.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' will be publicly viewable at or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at:
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-


I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA 
announced the availability of a guidance for industry entitled 
``Bioequivalence Recommendations for Specific Products,'' which 
explained the process that would be used to make product-specific BE 
recommendations available to the public on FDA's Web site at
    As described in that guidance, FDA adopted this process to develop 
and disseminate product-specific BE recommendations and to provide a 
meaningful opportunity for the public to consider and comment on those 
recommendations. This notice announces the availability of revised 
draft BE recommendations for lamotrigine extended-release tablets.
    On May 29, 2009, FDA initially approved new drug application 022115 
for LAMICTAL (lamotrigine) extended-release tablets. There are eight 
approved ANDAs for this product. In April 2010, we issued a draft 
guidance for industry on BE recommendations for lamotrigine extended-
release tablets, which we subsequently revised in May 2010; July 2010; 
and August 2010. We are now issuing a further revised draft guidance 
for industry on BE recommendations for generic lamotrigine extended-
release tablets (``Draft Guidance on Lamotrigine'').
    In October 2006, UCB, Inc., submitted a citizen petition requesting 
that FDA

[[Page 4917]]

take several actions with respect to anti-epileptic drugs (AEDs), 
including that FDA narrow the bioequivalence range for all such drugs 
(Docket No. FDA-2006-P-0461). FDA is reviewing the issues raised in the 
petition. Although lamotrigine is not the sole focus of the petition, 
lamotrigine is discussed and it is indicated for use as an AED; 
therefore, FDA will consider any comments on the draft guidance on 
lamotrigine in responding to the petition.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the design 
of BE studies to support ANDAs for lamotrigine extended-release 
tablets. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the document at 
either or

    Dated: January 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01683 Filed 1-27-16; 8:45 am]