[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Withdrawn From Sale for Reasons of Safety or Effectiveness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<Register> PresTab<Register>) 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(mg) was not withdrawn from sale for reasons of safety or 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 Under FDA regulations, drugs are withdrawn from the 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the listed drug was withdrawn from sale for reasons of safety or 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<Register> PresTab<Register> tablets that will not expire 
until April 10, 2007. This patent will prevent FDA from approving 
ANDA's that refer to Glynase<Register> PresTab<Register> 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<Register> PresTab<Register> 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