[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Determination That Cimetidine 100 mg Tablets Were Not Withdrawn 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cimetidine 100 milligram (mg) tablets were not withdrawn from sale for 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 Under FDA's regulations, drugs are withdrawn from the list if 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listed drug was withdrawn from sale for reasons of safety or 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