
[Federal Register: March 7, 2008 (Volume 73, Number 46)]
[Notices]               
[Page 12453-12454]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr08-89]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0130]

 
Determination That RELAFEN (Nabumetone) Tablets and Three Other 
Drug Products Were Not Withdrawn From Sale for Reasons of Safety or 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 the 
four drug products listed in this document were not withdrawn from sale 
for reasons of safety or effectiveness. This determination means that 
FDA will not begin procedures to withdraw approval of abbreviated new 
drug applications (ANDAs) that refer to the drug products, and it will 
allow FDA to continue to approve ANDAs that refer to the products as 
long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 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. Sponsors of ANDAs do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (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 (the 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).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) Before an ANDA that refers to that listed 
drug may be approved or (2) whenever a listed drug is voluntarily 
withdrawn from sale, and ANDAs that refer to the listed drug have been 
approved. Section 314.161(d) provides that if FDA determines that a 
listed drug was removed from sale for safety or effectiveness reasons, 
the agency will initiate proceedings that could result in the 
withdrawal of approval of the ANDAs that refer to the listed drug.
    FDA has become aware that the drug products listed in the table in 
this document are no longer being marketed.

------------------------------------------------------------------------
        NDA No.                    Drug                  Applicant
------------------------------------------------------------------------
19-583                   RELAFEN (nabumetone)     GlaxoSmithKline
                          Tablets, 500             (formerly
                          milligrams (mg) and      SmithKlineBeecham),
                          750 mg                   2301 Renaissance
                                                   Blvd., P.O. Box
                                                   161540,
                                                  King of Prussia, PA
                                                   19406-2772
------------------------------------------------------------------------
19-643                   MEVACOR (lovastatin)     Merck & Co., One Merck
                          Tablets, 10 mg           Dr., P.O. Box 100,
                                                   Whitehouse Station,
                                                   NJ 08889-0100
------------------------------------------------------------------------
50-416                   CORTISPORIN Ophthalmic   Monarch
                          Ointment (bacitracin     Pharmaceuticals,
                          zinc; hydrocortisone;    Inc., 501 Fifth
                          neomycin sulfate;        Street,
                          polymyxin B sulfate)    Bristol, TN 37620
                          400 units/gram (g); 1
                          percent; equivalent to
                          3.5 mg base/g; 10,000
                          units/g
------------------------------------------------------------------------
50-461                   ANCEF (cefazolin         GlaxoSmithKline
                          sodium) Injection, 250
                          mg base/vial, 500 mg
                          base/vial, 5 g base/
                          vial
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency

[[Page 12454]]

will continue to list the drug products listed in this document in the 
``Discontinued Drug Product List'' section of the Orange Book. The 
``Discontinued Drug Product List'' identifies, among other items, drug 
products that have been discontinued from marketing for reasons other 
than safety or effectiveness.
    Approved ANDAs that refer to the NDAs listed in this document are 
unaffected by the discontinued marketing of the products subject to 
those NDAs. Additional ANDAs for the products may also be approved by 
the agency if they comply with relevant legal and regulatory 
requirements. If FDA determines that labeling for these drug products 
should be revised to meet current standards, the agency will advise 
ANDA applicants to submit such labeling.

    Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4469 Filed 3-6-08; 8:45 am]

BILLING CODE 4160-01-S
