Federal Register / Vol. 72, No. 42 / Monday, March 5, 2007 / Notices 9763 

Place: John M. Eisenberg Building, AHRQ 

Conference Center, 540 Gaither Road, 

Rockville, Maryland 20850. 

Contact Person: Anyone wishing to obtain 

a roster of members, agenda or minutes of the 

non-confidential portions of this meeting 

should contact Mrs. Bonnie Campbell, 

Committee Management Officer, Office of 

Extramural Research, Education and Priority 

Populations, AHRQ, 540 Gaither Road, Room 

2038, Rockville, Maryland 20850, Telephone 

(301) 427–1554. 

Agenda items for this meeting are subject 

to change as priorities dictate. 

Dated: February 20, 2007. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 07–978 Filed 3–2–07; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Notice of Meeting 

In accordance with section 10(d) of 

the Federal Advisory Committee Act (5 

U.S.C., Appendix 2), announcement is 

made of a Health Care Policy and 

Research Special Emphasis Panel (SEP) 

meeting. 

A Special Emphasis Panel is a group 

of experts in fields related to health care 

research who are invited by the Agency 

for Healthcare Research and Quality 

(AHRQ), and agree to be available, to 

conduct on an as needed basis, 

scientific reviews of applications for 

AHRQ support. Individual members of 

the Panel do not attend regularlyscheduled meetings and do not serve for 

fixed terms or a long period of time. 

Rather, they are asked to participate in 

particular review meetings which 

require their type of expertise. 

Substantial segments of the upcoming 

SEP meeting listed below will be closed 

to the public in accordance with the 

Federal Advisory Committee Act, 

section 10(d) of 5 U.S.C., Appendix 2 

and 5 U.S.C. 552b(c)(6). Grant 

applications for ‘‘Consumer Assessment 

of Healthcare Providers and Systems 

(CAHPS)’’ are to be reviewed and 

discussed at this meeting. These 

discussions are likely to reveal personal 

information concerning individuals 

associated with the applications. This 

information is exempt from mandatory 

disclosure under the above-cited 

statutes. 

SEP Meeting on: Consumer Assessment of 

Healthcare Providers and Systems (CAHPS). 

Date: March 20, 2007 (Open on March 20 

from 9 a.m. to 8:15 a.m. and closed for the 

remainder of the meeting). 

Place: John M. Eisenberg Building, AHRQ 

Conference Center, 540 Gaither Road, 

Rockville, Maryland 20850. 

Contact Person: Anyone wishing to obtain 

a roster of members, agenda or minutes of the 

non-confidential portions of this meeting 

should contact Mrs. Bonnie Campbell, 

Committee Management Officer, Office of 

Extramural Research, Education and Priority 

Populations, AHRQ, 540 Gaither Road, Room 

2038, Rockville, Maryland 20850, Telephone 

(301) 427–1554. 

Agenda items for this meeting are subject 

to change as priorities dictate. 

Dated: February 20, 2007. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 07–979 Filed 3–2–07; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005P–0237] 

Determination That LAMICTAL 

(Lamotrigine) Tablets, 50 Milligrams 

and 250 Milligrams, Were Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that LAMICTAL (lamotrigine) tablets, 50 

milligrams (mg) and 250 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for lamotrigine 

tablets, 50 mg and 250 mg, if all other 

legal and regulatory requirements are 

met. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research (HFD–7), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

2041. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) (the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

sponsors must, with certain exceptions, 

show that the drug for which they are 

seeking approval contains the same 

active ingredient in the same strength 

and dosage form as the ‘‘listed drug,’’

which is typically a version of the drug 

that was previously approved. Sponsors 

of ANDAs do not have to repeat the 

extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’

which is generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are withdrawn from the list if the 

agency withdraws or suspends approval 

of the drug’s NDA or ANDA for reasons 

of safety or effectiveness or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (§ 314.162 (21 

CFR 314.162)). 

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

LAMICTAL (lamotrigine) tablets, 50 

mg and 250 mg, are the subject of 

approved NDA 20–241 held by 

GlaxoSmithKline (GSK). LAMICTAL 

(lamotrigine) is an antiepileptic drug 

indicated as adjunctive therapy for 

partial seizures in adults and pediatric 

patients. It is also approved for 

conversion to monotherapy in adults 

with partial seizures who are receiving 

treatment with a single enzymeinducing antiepileptic drug or valproate. 

In addition, LAMICTAL (lamotrigine) is 

indicated for the maintenance treatment 

of Bipolar I Disorder in certain patients. 

FDA approved the NDA for 

LAMICTAL (lamotrigine) tablets, 

including the 50 mg and 250 mg 

strengths, on December 27, 1994. GSK 

has never marketed the 50 mg and 250 

mg strengths of LAMICTAL 

(lamotrigine) tablets. 

In a citizen petition dated June 9, 

2005 (Docket No. 2005P–0237/CP1), 

submitted under 21 CFR 10.30, J. Mark 

Pohl of Pharmaceutical Patent 

Attorneys, LLC, requested that the 

agency determine whether LAMICTAL 

(lamotrigine) tablets, 50 mg and 250 mg, 

were withdrawn from sale for reasons of 

safety or effectiveness. After considering 

the citizen petition and reviewing 

agency records, FDA has determined 


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