[Federal Register Volume 72, Number 42 (Monday, March 5, 2007)]
[Notices]
[Pages 9763-9764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3713]


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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and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety 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.

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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withdrawn from sale for reasons of safety or effectiveness.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 Under FDA regulations, drugs are withdrawn from the list if the 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 
(Sec.  314.162 (21 CFR 314.162)).
    Under Sec.  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 enzyme-inducing 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

[[Page 9764]]

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 Sec. Sec.  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