[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Milligrams (mg)/45 mg, was not Withdrawn from Sale for Reasons of 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withdrawn from sale for reasons of safety or effectiveness.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 Under FDA regulations, drugs are withdrawn from the 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