80 FR 73770 - 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Milligrams, 325 Milligrams/15 Milligrams, 325 Milligrams/30 Milligrams, and 325 Milligrams/60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 227 (November 25, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 227 (November 25, 2015)
| Page Range | 73770-73771 | |
| FR Document | 2015-30051 |
[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)] [Notices] [Pages 73770-73771] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30051] ----------------------------------------------------------------------- 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Milligrams, 325 Milligrams/15 Milligrams, 325 Milligrams/30 Milligrams, and 325 Milligrams/60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- 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codeine phosphate) oral tablets, 325 milligrams (mg)/7.5 mg, 325 mg/15 mg, 325 mg/30 mg, and 325 mg/60 mg, were not withdrawn from sale for reasons of safety or effectiveness.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
![73770 Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices
combined file. CDC accepts file information for each PCNASP awardee based on evolving recommendations
transmissions as individual phases or is eight hours per response. and standards in the field to improve
combined. In addition, each PCNASP All patient, hospital, and EMS the quality of stroke care.
awardee will prepare an annual provider data that is submitted to CDC
OMB approval is requested for three
aggregate hospital inventory file for by PCNASP awardees will be de-
identified and occur through secure data years. Participation is voluntary and
transmission to CDC. The average there are no costs to respondents other
burden of reporting hospital inventory systems. Proposed data elements and
quality indicators may be updated over than their time. The total estimated
time to include new or revised items annualized burden hours are 382.
ESTIMATED ANNUALIZED BURDEN HOURS
Average bur-
Number of re-
Number of den per re-
Type of respondent Form name sponses per
respondents sponse
respondent (in hours)
PCNASP Hospital Partners ............................ Pre-hospital quality of care data .................... 78 4 15/60
Post-hospital quality of care data .................. 20 4 15/60
Hospital inventory data .................................. 315 1 30/60
PCNASP Awardee .......................................... Pre-hospital quality of care data .................... 9 4 30/60
In-hospital quality of care data ....................... 9 4 30/60
Post-hospital quality of care data .................. 9 4 30/60
Hospital inventory data .................................. 9 1 8
Leroy A. Richardson, and 325 mg/60 mg, if all other legal and A person may petition the Agency to
Chief, Information Collection Review Office, regulatory requirements are met. determine, or the Agency may
Office of Scientific Integrity, Office of the FOR FURTHER INFORMATION CONTACT: Jane determine on its own initiative, whether
Associate Director for Science, Office of the Baluss, Center for Drug Evaluation and a listed drug was withdrawn from sale
Director, Centers for Disease Control and for reasons of safety or effectiveness.
Research, Food and Drug
Prevention.
Administration, 10903 New Hampshire This determination may be made at any
[FR Doc. 2015–30061 Filed 11–24–15; 8:45 am] time after the drug has been withdrawn
Ave., Bldg. 51, Rm. 6278, Silver Spring,
BILLING CODE 4163–18–P from sale, but must be made prior to
MD 20993–0002, 301–796–3469.
SUPPLEMENTARY INFORMATION: In 1984, approving an ANDA that refers to the
Congress enacted the Drug Price listed drug (§ 314.161 (21 CFR 314.161)).
DEPARTMENT OF HEALTH AND FDA may not approve an ANDA that
HUMAN SERVICES Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417) does not refer to a listed drug.
Food and Drug Administration (the 1984 amendments), which TYLENOL WITH CODEINE
authorized the approval of duplicate (acetaminophen with codeine
[Docket No. FDA–2015–P–1153] versions of drug products under an phosphate) oral tablets, 325 mg/7.5 mg,
Determination That TYLENOL WITH ANDA procedure. ANDA applicants 325 mg/15 mg, 325 mg/30 mg, and 325
CODEINE (Acetaminophen With must, with certain exceptions, show that mg/60 mg, are the subject of ANDA 85–
the drug for which they are seeking 056 held by McNeil Ortho
Codeine Phosphate) Oral Tablets, 325
approval contains the same active Pharmaceuticals, Inc., and were initially
Milligrams/7.5 Milligrams, 325
ingredient in the same strength and approved July 9, 1976. TYLENOL WITH
Milligrams/15 Milligrams, 325
dosage form as the ‘‘listed drug,’’ which CODEINE is indicated for the relief of
Milligrams/30 Milligrams, and 325
is a version of the drug that was mild to moderately severe pain.
Milligrams/60 Milligrams, Were Not
previously approved. ANDA applicants
Withdrawn From Sale for Reasons of In a letter dated January 26, 1993,
do not have to repeat the extensive
Safety or Effectiveness McNeil Ortho Pharmaceuticals, Inc.
clinical testing otherwise necessary to
notified FDA that TYLENOL WITH
AGENCY: Food and Drug Administration, gain approval of a new drug application
CODEINE (acetaminophen with codeine
HHS. (NDA).
The 1984 amendments include what phosphate) oral tablets, 325 mg/7.5 mg,
ACTION: Notice. 325 mg/15 mg, 325 mg/30 mg, and 325
is now section 505(j)(7) of the Federal
SUMMARY: The Food and Drug Food, Drug, and Cosmetic Act (21 U.S.C. mg/60 mg, were being discontinued,
Administration (FDA or Agency) has 355(j)(7)), which requires FDA to and FDA moved the drug product to the
determined that TYLENOL WITH publish a list of all approved drugs. ‘‘Discontinued Drug Product List’’
CODEINE (acetaminophen with codeine FDA publishes this list as part of the section of the Orange Book.
phosphate) oral tablets, 325 milligrams ‘‘Approved Drug Products With Lachman Consultant Services, Inc.
(mg)/7.5 mg, 325 mg/15 mg, 325 mg/30 Therapeutic Equivalence Evaluations,’’ submitted a citizen petition dated April
mg, and 325 mg/60 mg, were not which is known generally as the 7, 2015 (Docket No. FDA–2015–P–
withdrawn from sale for reasons of ‘‘Orange Book.’’ Under FDA regulations, 1153), under 21 CFR 10.30, requesting
tkelley on DSK3SPTVN1PROD with NOTICES
safety or effectiveness. This drugs are removed from the list if the that the Agency determine whether
determination will allow FDA to Agency withdraws or suspends TYLENOL WITH CODEINE
approve abbreviated new drug approval of the drug’s NDA or ANDA (acetaminophen with codeine
applications (ANDAs) for TYLENOL for reasons of safety or effectiveness or phosphate) oral tablets, 325 mg/7.5 mg,
WITH CODEINE (acetaminophen with if FDA determines that the listed drug 325 mg/15 mg, 325 mg/30 mg, and 325
codeine phosphate) oral tablets, 325 mg/ was withdrawn from sale for reasons of mg/60 mg, were withdrawn from sale
7.5 mg, 325 mg/15 mg, 325 mg/30 mg, safety or effectiveness (21 CFR 314.162). for reasons of safety or effectiveness.
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![Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices 73771
After considering the citizen petition DEPARTMENT OF HEALTH AND that if you include your name, contact
and reviewing Agency records and HUMAN SERVICES information, or other information that
based on the information we have at this identifies you in the body of your
time, FDA has determined under Food and Drug Administration comments, that information will be
§ 314.161 that TYLENOL WITH [Docket No. FDA–2012–D–1197]
posted on http://www.regulations.gov.
CODEINE (acetaminophen with codeine • If you want to submit a comment
phosphate) oral tablets, 325 mg/7.5 mg, Certification Process for Designated with confidential information that you
325 mg/15 mg, 325 mg/30 mg, and 325 Medical Gases; Revised Draft do not wish to be made available to the
Guidance for Industry; Availability public, submit the comment as a
mg/60 mg, were not withdrawn for
written/paper submission and in the
reasons of safety or effectiveness. The AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper
petitioner has identified no data or other HHS. Submissions’’ and ‘‘Instructions’’).
information suggesting that TYLENOL
ACTION: Notice of availability. Written/Paper Submissions
WITH CODEINE (acetaminophen with
codeine phosphate) oral tablets, 325 mg/ SUMMARY: The Food and Drug Submit written/paper submissions as
7.5 mg, 325 mg/15 mg, 325 mg/30 mg, Administration (FDA or Agency) is follows:
and 325 mg/60 mg, were withdrawn for announcing the availability of a revised • Mail/Hand delivery/Courier (for
reasons of safety or effectiveness. We draft guidance for industry entitled written/paper submissions): Division of
have carefully reviewed our files for ‘‘Certification Process for Designated Dockets Management (HFA–305), Food
records concerning the withdrawal of Medical Gases.’’ The original version of and Drug Administration, 5630 Fishers
TYLENOL WITH CODEINE this draft guidance was published by Lane, Rm. 1061, Rockville, MD 20852.
(acetaminophen with codeine FDA on December 18, 2012. The revised • For written/paper comments
draft guidance, like the original version, submitted to the Division of Dockets
phosphate) oral tablets, 325 mg/7.5 mg,
describes the certification process Management, FDA will post your
325 mg/15 mg, 325 mg/30 mg, and 325
created by the Food and Drug comment, as well as any attachments,
mg/60 mg, from sale. We have also except for information submitted,
independently evaluated relevant Administration Safety and Innovation
Act (FDASIA) for certain medical gases marked and identified, as confidential,
literature and data for possible if submitted as detailed in
postmarketing adverse events. We have and explains how FDA plans to
implement that process. In response to ‘‘Instructions.’’
reviewed the available evidence and Instructions: All submissions received
determined that the product was not comments received, we have revised the
draft guidance and are reissuing it in must include the Docket No. FDA–
withdrawn from sale for reasons of 2012–D–1197 for ‘‘Certification Process
draft form to enable the public to review
safety or effectiveness. for Designated Medical Gases; Revised
and comment before it is finalized.
Accordingly, the Agency will Draft Guidance for Industry;
DATES: Although you can comment on
continue to list TYLENOL WITH Availability.’’ Received comments will
any guidance at any time (see 21 CFR be placed in the docket and, except for
CODEINE (acetaminophen with codeine 10.115(g)(5)), to ensure that the Agency
phosphate) oral tablets, 325 mg/7.5 mg, those submitted as ‘‘Confidential
considers your comment on this draft Submissions,’’ publicly viewable at
325 mg/15 mg, 325 mg/30 mg, and 325 guidance before it begins work on the http://www.regulations.gov or at the
mg/60 mg, in the ‘‘Discontinued Drug final version of the guidance, submit Division of Dockets Management
Product List’’ section of the Orange either electronic or written comments between 9 a.m. and 4 p.m., Monday
Book. The ‘‘Discontinued Drug Product on the draft guidance by January 25, through Friday.
List’’ delineates, among other items, 2016. Submit either electronic or • Confidential Submissions—To
drug products that have been written comments concerning the submit a comment with confidential
discontinued from marketing for reasons collection of information proposed in information that you do not wish to be
other than safety or effectiveness. the draft guidance and attached Form made publicly available, submit your
ANDAs that refer to TYLENOL WITH 3864 by January 25, 2016. comments only as a written/paper
CODEINE (acetaminophen with codeine ADDRESSES: You may submit comments submission. You should submit two
phosphate) oral tablets, 325 mg/7.5 mg, as follows: copies total. One copy will include the
325 mg/15 mg, 325 mg/30 mg, and 325 information you claim to be confidential
mg/60 mg, may be approved by the Electronic Submissions with a heading or cover note that states
Agency as long as they meet all other Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
legal and regulatory requirements for following way: CONFIDENTIAL INFORMATION.’’ The
the approval of ANDAs. If FDA • Federal eRulemaking Portal: http:// Agency will review this copy, including
determines that labeling for this drug www.regulations.gov. Follow the the claimed confidential information, in
product should be revised to meet instructions for submitting comments. its consideration of comments. The
current standards, the Agency will Comments submitted electronically, second copy, which will have the
advise ANDA applicants to submit such including attachments, to http:// claimed confidential information
labeling. www.regulations.gov will be posted to redacted/blacked out, will be available
the docket unchanged. Because your for public viewing and posted on http://
Dated: November 20, 2015. comment will be made public, you are www.regulations.gov. Submit both
Leslie Kux, solely responsible for ensuring that your copies to the Division of Dockets
tkelley on DSK3SPTVN1PROD with NOTICES
Associate Commissioner for Policy. comment does not include any Management. If you do not wish your
[FR Doc. 2015–30051 Filed 11–24–15; 8:45 am] confidential information that you or a name and contact information to be
BILLING CODE 4164–01–P
third party may not wish to be posted, made publicly available, you can
such as medical information, your or provide this information on the cover
anyone else’s Social Security number, or sheet and not in the body of your
confidential business information, such comments and you must identify this
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
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Document Created: 2018-03-01 11:15:40
Document Modified: 2018-03-01 11:15:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 80 FR 73770 |
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