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Milligrams (mg)/45 mg, was not Withdrawn from Sale for Reasons of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withdrawn from sale for reasons of safety or effectiveness.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 Under FDA regulations, drugs are withdrawn from the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