[Federal Register Volume 61, Number 99 (Tuesday, May 21, 1996)]
[Notices]
[Page 25497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12759]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95P-0285]
Determination That Glyburide Tablets 4.5 Milligrams Was 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Withdrawn From Sale for Reasons of Safety or Effectiveness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
glyburide (Glynase PresTab) tablets 4.5 milligrams
(mg) was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow sponsors to submit
abbreviated new drug applications (ANDA's) for glyburide tablets 4.5
mg.
FOR FURTHER INFORMATION CONTACT: Wayne H. Mitchell, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1049.
SUPPLEMENTARY INFORMATION: In 1984, Congress passed into law the Drug
Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 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 a version of
the drug that was previously approved under a new drug application
(NDA). Sponsors of ANDA's do not have to repeat the extensive clinical
testing otherwise necessary to gain approval of an 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 included what is now section 505(j)(6) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(6)),
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 Under FDA regulations, drugs are withdrawn from the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the listed drug was withdrawn from sale for reasons of safety or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)). Another FDA regulation
also provides that the agency must make a determination as to 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 (Sec. 314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not
approve an ANDA that does not refer to a listed drug.
Novopharm Ltd., submitted a citizen petition, dated August 21, 1995
(Docket No. 95P-0285/CP1), under 21 CFR 10.25(a) and 10.30 requesting
that the agency determine whether glyburide tablets 4.5 mg was
withdrawn from sale for reasons of safety or effectiveness and, if the
agency determines that the drug was not withdrawn from sale for reasons
of safety or effectiveness, to keep the drug in the ``Approved Drug
Products with Therapeutic Equivalence Evaluations.'' Glyburide tablets
4.5 mg, along with the 1.5-mg, 3-mg, and 6-mg strengths, is the subject
of approved NDA 20-051 held by the Upjohn Co. (Upjohn). Upjohn obtained
approval to market the 4.5-mg strength of glyburide tablets on
September 24, 1993. Upjohn has never marketed the 4.5-mg strength of
glyburide tablets. FDA has determined, for purposes of Secs. 314.161
and 314.162(c), that never marketing an approved drug product is
equivalent to withdrawing the drug for sale.
FDA has reviewed its records and, under Secs. 314.161 and
314.162(c), has determined that glyburide tablets 4.5 mg was not
withdrawn from sale for reasons of safety or effectiveness and will
continue to list glyburide tablets 4.5 mg in the ``Discontinued Drug
Product List'' contained in the ``Approved Drug Products with
Therapeutic Equivalence Evaluations.'' The ``Discontinued Drug Product
List'' lists, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDA's that refer to glyburide tablets 4.5 mg may be
submitted to the agency.
The agency notes that there is a patent listed in the Orange Book
for Glynase PresTab tablets that will not expire
until April 10, 2007. This patent will prevent FDA from approving
ANDA's that refer to Glynase PresTab tablets with
an effective date before April 10, 2007, if the patent is valid and the
manufacture, use, or sale of the drug product for which approval is
being sought would infringe the patent. Novopharm Ltd., states in its
petition that it does not intend to make a generic drug that refers to
Glynase PresTab tablets available for sale until
the expiration of the patent. Between now and the time an ANDA for
glyburide tablets 4.5 mg is submitted, approved, or the approval goes
into effect, FDA may obtain new information on the safety and
effectiveness of glyburide tablets that will prevent the agency from
receiving or approving the ANDA.
Dated: May 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-12759 Filed 5-20-96; 8:45 am]
BILLING CODE 4160-01-F