83 FR 3157 - Watson Laboratories, Inc.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 15 (January 23, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 15 (January 23, 2018)
| Page Range | 3157-3158 | |
| FR Document | 2018-01118 |
[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)] [Notices] [Pages 3157-3158] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01118] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0021] Watson Laboratories, Inc.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA and Agency) is withdrawing approval of an abbreviated new drug application (ANDA), held by Watson Laboratories, Inc. (Watson), for prescription pain medications that contain more than 325 milligrams (mg) of acetaminophen. Watson has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing. DATES: Approval is withdrawn as of January 23, 2018. 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 the Federal Register of January 14, 2011 (76 FR 2691), FDA announced its plans to reduce the maximum dosage unit strength of acetaminophen in prescription drug products. The document announced FDA's conclusion that, based on a reevaluation of the relative risks and benefits of prescription acetaminophen products, fixed-combination prescription drugs containing more than 325 mg of acetaminophen per dosage unit (tablet or capsule) do not provide a sufficient margin of safety to protect the public against the serious risk of acetaminophen-induced liver injury. Accordingly, we asked product sponsors to limit the maximum amount of acetaminophen per dosage unit to 325 mg and, for those products containing more than 325 mg of acetaminophen per dosage unit, to submit requests that FDA withdraw approval of their applications under Sec. 314.150(d) (21 CFR 314.150(d)). FDA asked that all such requests be made before January 14, 2014, after which date the Agency planned to initiate proceedings under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)). In a Federal Register document dated March 27, 2014 (79 FR 17613), [[Page 3158]] FDA withdrew the approval of multiple applications containing more than 325 mg of acetaminophen whose sponsors voluntarily requested withdrawal and waived their opportunity for a hearing on or before that date. In a letter dated November 22, 2016, Watson voluntarily requested that FDA withdraw approval of its ANDA 074699 for Pentazocine and Acetaminophen Tablets, 25 mg/650 mg, and waived its opportunity for a hearing. The letter also stated that the product was not manufactured or distributed after January 14, 2014. Therefore, under Sec. 314.150(d), approval of this ANDA, and all amendments and supplements thereto, is withdrawn (see DATES). Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). The safety issue discussed in this document and the January 14, 2011, Federal Register document is limited to products containing more than 325 mg of acetaminophen per dosage unit. Thus, the withdrawal of approval of this product does not change the approval status of any product with 325 mg or less of acetaminophen per dosage unit that is approved under the same application, or that refers to or relies on the withdrawn application. Dated: January 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01118 Filed 1-22-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3157
Administration, 10903 New Hampshire presentations should notify the contact DEPARTMENT OF HEALTH AND
Ave., Bldg. 32, Rm. 5154, Silver Spring, person and submit a brief statement of HUMAN SERVICES
MD 20993, 240–402–3838, email: the general nature of the evidence or
marieann.brill@fda.hhs.gov, or FDA arguments they wish to present, the Food and Drug Administration
Advisory Committee Information Line, names and addresses of proposed [Docket No. FDA–2011–N–0021]
1–800–741–8138 (301–443–0572 in the participants, and an indication of the
Washington, DC area). A notice in the approximate time requested to make Watson Laboratories, Inc.; Withdrawal
Federal Register about last minute their presentation on or before March 7, of Approval of Abbreviated New Drug
modifications that impact a previously 2018. Time allotted for each Applications for Prescription Pain
announced advisory committee meeting presentation may be limited. If the Medications Containing More Than 325
cannot always be published quickly number of registrants requesting to Milligrams of Acetaminophen
enough to provide timely notice. speak is greater than can be reasonably
Therefore, you should always check the AGENCY: Food and Drug Administration,
accommodated during the scheduled HHS.
Agency’s website at https://
open public hearing session, FDA may ACTION: Notice.
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the conduct a lottery to determine the
appropriate advisory committee meeting speakers for the scheduled open public SUMMARY: The Food and Drug
link, or call the advisory committee hearing session. The contact person will Administration (FDA and Agency) is
information line to learn about possible notify interested persons regarding their withdrawing approval of an abbreviated
modifications before coming to the request to speak by March 8, 2017. new drug application (ANDA), held by
meeting. Closed Committee Deliberations: On Watson Laboratories, Inc. (Watson), for
prescription pain medications that
SUPPLEMENTARY INFORMATION: March 22, 2018, from 8:30 a.m. to 10
contain more than 325 milligrams (mg)
Agenda: The PAC and EMDAC will a.m., the meeting will be closed to
of acetaminophen. Watson has
meet to discuss the major objectives of permit committee review and
voluntarily requested that approval of
a phase 3 drug development program discussion of trade secret and/or this application be withdrawn and has
indicated for the treatment of children confidential commercial information (5 waived its opportunity for a hearing.
with achondroplasia (ACH). The U.S.C. 552b(c)(4)) included in an
DATES: Approval is withdrawn as of
following elements of a phase 3 program Investigational New Drug application
January 23, 2018.
should be considered for discussion: for an investigational product indicated
Evidence required to establish dose- FOR FURTHER INFORMATION CONTACT: Jane
for the treatment of children with ACH.
response, study design, e.g., placebo Baluss, Center for Drug Evaluation and
Persons attending FDA’s advisory Research, Food and Drug
control, study duration, intended
committee meetings are advised that Administration, 10903 New Hampshire
population, e.g., infants and toddlers
FDA is not responsible for providing Ave., Bldg. 51, Rm. 6278, Silver Spring,
and/or older children and adolescents,
access to electrical outlets. MD 20993–0002, 301–796–3469.
and endpoints that have a clinically
meaningful impact on the patient’s FDA welcomes the attendance of the SUPPLEMENTARY INFORMATION: In the
functional or psychological well-being. public at its advisory committee Federal Register of January 14, 2011 (76
Comments about the upcoming advisory meetings and will make every effort to FR 2691), FDA announced its plans to
committee meeting should be submitted accommodate persons with disabilities. reduce the maximum dosage unit
to Docket No. FDA–2018–N–0045. If you require accommodations due to a strength of acetaminophen in
FDA intends to make background disability, please contact Marieann Brill prescription drug products. The
material available to the public no later (See, FOR FURTHER INFORMATION document announced FDA’s conclusion
than 2 business days before the meeting. CONTACT) at least 7 days in advance of that, based on a reevaluation of the
If FDA is unable to post the background the meeting. relative risks and benefits of
material on its website prior to the prescription acetaminophen products,
meeting, the background material will FDA is committed to the orderly fixed-combination prescription drugs
be made publicly available at the conduct of its advisory committee containing more than 325 mg of
location of the advisory committee meetings. Please visit our website at acetaminophen per dosage unit (tablet
meeting, and the background material https://www.fda.gov/Advisory or capsule) do not provide a sufficient
will be posted on FDA’s website after Committees/AboutAdvisoryCommittees/ margin of safety to protect the public
the meeting. Background material is ucm111462.htm for procedures on against the serious risk of
available at https://www.fda.gov/ public conduct during advisory acetaminophen-induced liver injury.
AdvisoryCommittees/Calendar/ committee meetings. Accordingly, we asked product sponsors
default.htm. Scroll down to the Notice of this meeting is given under to limit the maximum amount of
appropriate advisory committee meeting the Federal Advisory Committee Act (5 acetaminophen per dosage unit to 325
link. U.S.C. app. 2). mg and, for those products containing
Procedure: On March 22, 2018, from more than 325 mg of acetaminophen per
10:30 a.m. to 5:30 p.m., the meeting is Dated: January 17, 2018. dosage unit, to submit requests that FDA
open to the public. Interested persons Leslie Kux, withdraw approval of their applications
may present data, information, or views, Associate Commissioner for Policy. under § 314.150(d) (21 CFR 314.150(d)).
orally or in writing, on issues pending FDA asked that all such requests be
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2018–01120 Filed 1–22–18; 8:45 am]
before the committee. Written BILLING CODE 4164–01–P
made before January 14, 2014, after
submissions may be made to the contact which date the Agency planned to
person on or before March 15, 2018. initiate proceedings under section
Oral presentations from the public will 505(e) of the Federal Food, Drug, and
be scheduled between approximately 1 Cosmetic Act (FD&C Act) (21 U.S.C.
p.m. and 2 p.m. Those individuals 355(e)). In a Federal Register document
interested in making formal oral dated March 27, 2014 (79 FR 17613),
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![3158 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices
FDA withdrew the approval of multiple proposed collection of information, Staff, FDA will post your comment, as
applications containing more than 325 including each proposed collection of well as any attachments, except for
mg of acetaminophen whose sponsors information, and to allow 60 days for information submitted, marked and
voluntarily requested withdrawal and public comment in response to the identified, as confidential, if submitted
waived their opportunity for a hearing notice. This notice solicits comments on as detailed in ‘‘Instructions.’’
on or before that date. ‘‘Draft Guidance for Industry: Modified Instructions: All submissions received
In a letter dated November 22, 2016, Risk Tobacco Product Applications’’ must include the Docket No. FDA–
Watson voluntarily requested that FDA (MRTPA). 2012–D–0071 for ‘‘Draft Guidance for
withdraw approval of its ANDA 074699 DATES: Submit either electronic or Industry: Modified Risk Tobacco
for Pentazocine and Acetaminophen written comments on the collection of Product Applications’’ Received
Tablets, 25 mg/650 mg, and waived its information by March 26, 2018. comments, those filed in a timely
opportunity for a hearing. The letter also ADDRESSES: You may submit comments manner (see ADDRESSES), will be placed
stated that the product was not as follows. Please note that late, in the docket and, except for those
manufactured or distributed after untimely filed comments will not be submitted as ‘‘Confidential
January 14, 2014. considered. Electronic comments must Submissions,’’ publicly viewable at
Therefore, under § 314.150(d), be submitted on or before March 26, https://www.regulations.gov or at the
approval of this ANDA, and all 2018. The https://www.regulations.gov Dockets Management Staff between 9
amendments and supplements thereto, electronic filing system will accept a.m. and 4 p.m., Monday through
is withdrawn (see DATES). Distribution comments until midnight Eastern Time Friday.
of this product in interstate commerce at the end of March 26, 2018. Comments • Confidential Submissions—To
without an approved application is received by mail/hand delivery/courier submit a comment with confidential
illegal and subject to regulatory action (for written/paper submissions) will be information that you do not wish to be
(see sections 505(a) and 301(d) of the considered timely if they are made publicly available, submit your
FD&C Act (21 U.S.C. 355(a) and 331(d)). postmarked or the delivery service comments only as a written/paper
The safety issue discussed in this acceptance receipt is on or before that submission. You should submit two
document and the January 14, 2011, date. copies total. One copy will include the
Federal Register document is limited to information you claim to be confidential
products containing more than 325 mg Electronic Submissions with a heading or cover note that states
of acetaminophen per dosage unit. Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Thus, the withdrawal of approval of this following way: CONFIDENTIAL INFORMATION.’’ The
product does not change the approval • Federal eRulemaking Portal: Agency will review this copy, including
status of any product with 325 mg or https://www.regulations.gov. Follow the the claimed confidential information, in
less of acetaminophen per dosage unit instructions for submitting comments. its consideration of comments. The
that is approved under the same Comments submitted electronically, second copy, which will have the
application, or that refers to or relies on including attachments, to https:// claimed confidential information
the withdrawn application. www.regulations.gov will be posted to redacted/blacked out, will be available
Dated: January 17, 2018.
the docket unchanged. Because your for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
Leslie Kux,
solely responsible for ensuring that your both copies to the Dockets Management
Associate Commissioner for Policy. comment does not include any Staff. If you do not wish your name and
[FR Doc. 2018–01118 Filed 1–22–18; 8:45 am] confidential information that you or a contact information to be made publicly
BILLING CODE 4164–01–P third party may not wish to be posted, available, you can provide this
such as medical information, your or information on the cover sheet and not
anyone else’s Social Security number, or in the body of your comments and you
DEPARTMENT OF HEALTH AND confidential business information, such must identify this information as
HUMAN SERVICES as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Food and Drug Administration information, or other information that except in accordance with 21 CFR 10.20
[Docket No. FDA–2012–D–0071] identifies you in the body of your and other applicable disclosure law. For
comments, that information will be more information about FDA’s posting
Agency Information Collection posted on https://www.regulations.gov. of comments to public dockets, see 80
Activities; Proposed Collection; • If you want to submit a comment FR 56469, September 18, 2015, or access
Comment Request; Draft Guidance for with confidential information that you the information at: https://www.gpo.gov/
Industry: Modified Risk Tobacco do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
Product Applications public, submit the comment as a 23389.pdf.
written/paper submission and in the Docket: For access to the docket to
AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper
HHS. read background documents or the
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
ACTION: Notice.
Written/Paper Submissions received, go to https://
SUMMARY: The Food and Drug Submit written/paper submissions as www.regulations.gov and insert the
Administration (FDA or Agency) is docket number, found in brackets in the
sradovich on DSK3GMQ082PROD with NOTICES
follows:
announcing an opportunity for public • Mail/Hand delivery/Courier (for heading of this document, into the
comment on the proposed collection of written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
certain information by the Agency. Management Staff (HFA–305), Food and and/or go to the Dockets Management
Under the Paperwork Reduction Act of Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
1995 (PRA), Federal Agencies are Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
required to publish notice in the • For written/paper comments FOR FURTHER INFORMATION CONTACT:
Federal Register concerning each submitted to the Dockets Management Amber Sanford, Office of Operations,
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Document Created: 2018-01-23 01:08:40
Document Modified: 2018-01-23 01:08:40
| 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. | |
| Dates | Approval is withdrawn as of January 23, 2018. | |
| 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 | 83 FR 3157 |
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