[Federal Register: March 5, 2007 (Volume 72, Number 42)]
[Notices]
[Page 9763-9764]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr07-52]
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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and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety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withdrawn from sale for reasons of safety or effectiveness.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 Under FDA regulations, drugs are withdrawn from the list if the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