[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)]
[Notices]
[Pages 73770-73771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30051]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-P-1153]


Determination That TYLENOL WITH CODEINE (Acetaminophen With 
Codeine Phosphate) Oral Tablets, 325 Milligrams/7.5 Milligrams, 325 
Milligrams/15 Milligrams, 325 Milligrams/30 Milligrams, and 325 
Milligrams/60 Milligrams, Were Not Withdrawn From Sale for Reasons of 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 or Agency) has 
determined that TYLENOL WITH CODEINE (acetaminophen with codeine 
phosphate) oral tablets, 325 milligrams (mg)/7.5 mg, 325 mg/15 mg, 325 
mg/30 mg, and 325 mg/60 mg, were not withdrawn from sale for reasons of 
safety or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDAs) for TYLENOL WITH CODEINE 
(acetaminophen with codeine phosphate) oral tablets, 325 mg/7.5 mg, 325 
mg/15 mg, 325 mg/30 mg, and 325 mg/60 mg, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Jane Baluss, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6278, Silver Spring, MD 20993-0002, 301-
796-3469.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted 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 under an ANDA procedure. ANDA applicants 
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. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    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 known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed 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).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    TYLENOL WITH CODEINE (acetaminophen with codeine phosphate) oral 
tablets, 325 mg/7.5 mg, 325 mg/15 mg, 325 mg/30 mg, and 325 mg/60 mg, 
are the subject of ANDA 85-056 held by McNeil Ortho Pharmaceuticals, 
Inc., and were initially approved July 9, 1976. TYLENOL WITH CODEINE is 
indicated for the relief of mild to moderately severe pain.
    In a letter dated January 26, 1993, McNeil Ortho Pharmaceuticals, 
Inc. notified FDA that TYLENOL WITH CODEINE (acetaminophen with codeine 
phosphate) oral tablets, 325 mg/7.5 mg, 325 mg/15 mg, 325 mg/30 mg, and 
325 mg/60 mg, were being discontinued, and FDA moved the drug product 
to the ``Discontinued Drug Product List'' section of the Orange Book.
    Lachman Consultant Services, Inc. submitted a citizen petition 
dated April 7, 2015 (Docket No. FDA-2015-P-1153), under 21 CFR 10.30, 
requesting that the Agency determine whether TYLENOL WITH CODEINE 
(acetaminophen with codeine phosphate) oral tablets, 325 mg/7.5 mg, 325 
mg/15 mg, 325 mg/30 mg, and 325 mg/60 mg, were withdrawn from sale for 
reasons of safety or effectiveness.

[[Page 73771]]

    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that TYLENOL WITH CODEINE (acetaminophen with 
codeine phosphate) oral tablets, 325 mg/7.5 mg, 325 mg/15 mg, 325 mg/30 
mg, and 325 mg/60 mg, were not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that TYLENOL WITH CODEINE (acetaminophen with 
codeine phosphate) oral tablets, 325 mg/7.5 mg, 325 mg/15 mg, 325 mg/30 
mg, and 325 mg/60 mg, were withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of TYLENOL WITH CODEINE (acetaminophen with 
codeine phosphate) oral tablets, 325 mg/7.5 mg, 325 mg/15 mg, 325 mg/30 
mg, and 325 mg/60 mg, from sale. We have also independently evaluated 
relevant literature and data for possible postmarketing adverse events. 
We have reviewed the available evidence and determined that the product 
was not withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list TYLENOL WITH CODEINE 
(acetaminophen with codeine phosphate) oral tablets, 325 mg/7.5 mg, 325 
mg/15 mg, 325 mg/30 mg, and 325 mg/60 mg, 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. ANDAs that refer to TYLENOL WITH CODEINE (acetaminophen 
with codeine phosphate) oral tablets, 325 mg/7.5 mg, 325 mg/15 mg, 325 
mg/30 mg, and 325 mg/60 mg, may be approved by the Agency as long as 
they meet all other legal and regulatory requirements for the approval 
of ANDAs. If FDA determines that labeling for this drug product should 
be revised to meet current standards, the Agency will advise ANDA 
applicants to submit such labeling.

    Dated: November 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-30051 Filed 11-24-15; 8:45 am]
BILLING CODE 4164-01-P