[Federal Register Volume 63, Number 99 (Friday, May 22, 1998)]
[Notices]
[Pages 28387-28388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13650]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98P-0160]
Determination That Cimetidine 100 mg Tablets Were Not Withdrawn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
cimetidine 100 milligram (mg) tablets were not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDA's) for drugs that
refer to cimetidine 100 mg tablets.
FOR FURTHER INFORMATION CONTACT: Virginia G. Beakes, 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 (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 (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 Under FDA's regulations, drugs are withdrawn from the list if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listed drug was withdrawn from sale for reasons of safety or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 (21 CFR 314.162). Regulations also provide 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.
In citizen petitions dated March 9, 1998 (Docket No. 98P-0160/CP
1), and March 13, 1998 (Docket No. 98P-0160/CP 2), submitted in
accordance with 21 CFR 314.122, Apotex Corp. and Novopharm Limited,
respectively, requested that the agency determine whether cimetidine
(Tagamet HB) 100 mg tablets were withdrawn from sale for reasons of
safety or effectiveness. Cimetidine 100 mg tablets are the subject of
approved NDA 20-238 held by SmithKline Beecham Consumer Healthcare LP
(SmithKline Beecham). In 1997, SmithKline Beecham withdrew cimetidine
100 mg tablets from sale.
FDA has reviewed its records and, under Sec. 314.161, has
determined that cimetidine 100 mg tablets were not withdrawn from sale
for reasons of safety or effectiveness. Accordingly, the agency will
maintain cimetidine 100 mg tablets 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 or
effectiveness. ANDA's that refer to cimetidine 100 mg tablets may be
approved by the agency.
[[Page 28388]]
Dated: May 14, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-13650 Filed 5-21-98; 8:45 am]
BILLING CODE 4160-01-F
