9764 Federal Register / Vol. 72, No. 42 / Monday, March 5, 2007 / Notices 

that LAMICTAL (lamotrigine) tablets, 50 

mg and 250 mg, were not withdrawn 

from sale for reasons of safety or 

effectiveness. To date, GSK has not 

marketed LAMICTAL (lamotrigine) 

tablets, 50 mg and 250 mg. In previous 

instances (see, e.g., 67 FR 79640, 

December 30, 2002 (addressing a 

relisting request for Diazepam 

Autoinjector)), the agency has 

determined that, for purposes of 

§§ 314.161 and 314.162, never 

marketing an approved drug product is 

equivalent to withdrawing the drug 

from sale. 

The petitioner identified no data or 

other information suggesting that 

LAMICTAL (lamotrigine) tablets, 50 mg 

and 250 mg, were withdrawn from sale 

as a result of safety or effectiveness 

concerns. GSK has marketed other 

strengths of LAMICTAL (lamotrigine) 

tablets: 25 mg, 100 mg, 150 mg, and 200 

mg. FDA has reviewed its files for 

records concerning the withdrawal of 

LAMICTAL (Lamotrigine) tablets, 50 mg 

and 250 mg. There is no indication that 

GSK’s decision not to market 

LAMICTAL (lamotrigine) tablets, 50 mg 

and 250 mg, commercially is a function 

of safety or effectiveness concerns, and 

no information has been submitted to 

the docket concerning the reason for 

which LAMICTAL (lamotrigine) tablets, 

50 mg and 250 mg, were withdrawn 

from sale. FDA’s independent 

evaluation of relevant information has 

uncovered nothing that would indicate 

that LAMICTAL (lamotrigine) tablets, 50 

mg and 250 mg, were withdrawn from 

sale for reasons of safety or 

effectiveness. 

For the reasons outlined in this 

document, FDA has determined that 

LAMICTAL (lamotrigine) tablets, 50 mg 

and 250 mg, were not withdrawn from 

sale for reasons of safety or 

effectiveness. Accordingly, the agency 

will continue to list LAMICTAL 

(lamotrigine) tablets, 50 mg and 250 mg, 

in the ‘‘Discontinued Drug Product List’’

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety and effectiveness. ANDAs that 

refer to LAMICTAL (lamotrigine) 

tablets, 50 mg and 250 mg, may be 

approved by the agency, as long as they 

meet all relevant legal and regulatory 

requirements for approval of ANDAs. 

Dated: February 26, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3713 Filed 3–2–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Joint Meeting of the Anti-Infective 

Drugs Advisory Committee and the 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committees: Anti-Infective 

Drugs Advisory Committee and the 

Pediatric Advisory Committee. 

General Function of the Committees: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 12, 2007, from 8:30 a.m. 

to 5 p.m. 

Location: Food and Drug 

Administration, Center for Drug 

Evaluation and Research Advisory 

Committee Conference Room, rm. 1066, 

5630 Fishers Lane, Rockville, MD. 

Contact Person: Sohail Mosaddegh, 

Center for Drug Evaluation and Research 

(HFD–21), Food and Drug 

Administration, 5600 Fishers Lane (for 

express delivery, 5630 Fishers Lane, rm. 

1093), Rockville, MD 20857, 301–827–

7001, FAX: 301–827–6776, e-mail: 

sohail.mosaddegh@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington DC area), codes 3014512530 

or 8732310001. Please call the 

Information Line for up-to-date 

information on this meeting. 

Agenda: The committee will discuss 

clinical trial designs for products that 

seek indications for the prevention and/ 

or treatment of disease caused by Shiga 

toxin-producing bacteria. FDA intends 

to make background material available 

to the public no later than 1 business 

day before the meeting. If FDA is unable 

to post the background material on its 

Web site prior to the meeting, the 

background material will be made 

publicly available at the location of the 

advisory committee meeting, and the 

background material will be posted on 

FDA’s Web site after the meeting. 

Background material is available at 

http://www.fda.gov/ohrms/dockets/ac/ 

acmenu.htm, click on the year 2007 and 

scroll down to the appropriate advisory 

committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 29, 2007. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before March 21, 2007. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 22, 2007. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Sohail 

Mosaddegh at least 7 days in advance of 

the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 26, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–3720 Filed 3–2–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0055] 

Arthritis Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 


erjones on PRODPC74 with NOTICES