96-17472. Determination that Acetaminophen and Codeine Tablets USP, 325 Milligrams (mg)/45 mg, was not Withdrawn from Sale for Reasons of Safety or Effectiveness  

  • [Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
    [Notices]
    [Pages 36385-36386]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-17472]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Food and Drug Administration
    [Docket No. 96P-0083]
    
    
    Determination that Acetaminophen and Codeine Tablets USP, 325 
    Milligrams (mg)/45 mg, was not Withdrawn from Sale for Reasons of 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 
    acetaminophen and codeine phosphate tablets USP, 325 mg/45 mg, was not 
    withdrawn from sale for reasons of safety or effectiveness. This 
    determination will allow abbreviated new drug applications (ANDA's) for 
    acetaminophen and codeine phosphate tablets USP, 325 mg/45 mg to be 
    approved.
    
    FOR FURTHER INFORMATION CONTACT:  Christine F. Rogers, Center for Drug 
    Evaluation and Research (HFD-7), Food and Drug Administration, 7520 
    Standish Pl., Rockville, MD 20855, 301-594-2041.
    
    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,
    
    [[Page 36386]]
    
    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)). 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.
        Mikart Inc. (Mikart) submitted a citizen petition dated February 
    27, 1996 (Docket No. 96P-0083/CP1), under 21 CFR 10.30(b) and 
    314.122(a), requesting that the agency determine whether acetaminophen 
    and codeine phosphate tablets USP, 325 mg/45 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.'' Acetaminophen and 
    codeine phosphate tablets USP, 325 mg/45 mg, is the subject of approved 
    ANDA 85-363 held by KV Pharmaceuticals (KV). KV obtained approval of 
    the ANDA on August 23, 1977, but has never marketed the product. 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 Sec. Sec.  314.161 and 
    314.162(c), has determined that acetaminophen and codeine phosphate 
    tablets USP, 325 mg/45 mg, was not withdrawn from sale for reasons of 
    safety or effectiveness and will continue to list acetaminophen and 
    codeine phosphate tablets USP, 325 mg/45 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 acetaminophen and codeine phosphate 
    tablets USP, 325 mg/45 mg, may be approved by the agency.
    
        Dated: July 2, 1996.
    William K. Hubbard,
    Associate Commissioner for Policy Coordination.
    [FR Doc. 96-17472 Filed 7-9-96; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
07/10/1996
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
96-17472
Pages:
36385-36386 (2 pages)
Docket Numbers:
Docket No. 96P-0083
PDF File:
96-17472.pdf