[Federal Register Volume 65, Number 120 (Wednesday, June 21, 2000)]
[Notices]
[Page 38561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15555]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P-0842]


Determination That Ranitidine Effervescent 75-Milligram Tablet 
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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) is announcing its 
determination that ranitidine effervescent 75-milligram (mg) tablet 
(Zantac Efferdose) was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDA's) for ranitidine effervescent 75-mg 
tablet.

FOR FURTHER INFORMATION CONTACT: Andrea C. Masciale, 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 (the 1984 
amendments) (Public Law 98-417), 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 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 Under FDA regulations, drugs are withdrawn from the list if the 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 (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.
    Ranitidine effervescent 75-mg tablet is the subject of NDA 20-745. 
FDA approved NDA 20-745, held by Glaxo Wellcome, Inc. (Glaxo), on 
February 26, 1998. Glaxo never marketed the ranitidine effervescent 75-
mg tablet. Glaxo transferred ownership of NDA 20-745 to the Warner-
Lambert Co. (Warner-Lambert) effective January 1, 1999. To date, 
Warner-Lambert has not marketed the ranitidine effervescent 75-mg 
tablet.
    On March 1, 2000, Thomas Blake, R.Ph., submitted a citizen petition 
(Docket No. 00P-0842/CP1) under 21 CFR 10.30 to FDA. The petition 
requested that the agency determine whether ranitidine effervescent 75-
mg tablet was withdrawn from sale for reasons of safety or 
effectiveness. FDA has determined that, for the purposes of 
Sec. 314.161, never marketing an approved drug product is equivalent to 
withdrawing the drug product from sale.
    FDA has reviewed its records and, under Sec. 314.161, has 
determined that the decision by Glaxo and Warner-Lambert not to market 
ranitidine effervescent 75-mg tablet was not for reasons of safety or 
effectiveness. Accordingly, the agency will maintain ranitidine 
effervescent 75-mg tablet 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 ranitidine effervescent 75-mg 
tablet may be approved by the agency.

    Dated: June 14, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-15555 Filed 6-20-00; 8:45 am]
BILLING CODE 4160-01-F