Mylan Pharmaceuticals Inc., et.al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications, 12942-12943 [2023-04175]
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12942
Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES
Regarding the ICH: Jill Adleberg,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6364, Silver Spring,
MD 20993–0002, 301–796–5259,
Jill.Adleberg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘Q13
Continuous Manufacturing of Drug
Substances and Drug Products.’’ The
guidance was prepared under the
auspices of ICH. ICH seeks to achieve
greater regulatory harmonization
worldwide to ensure that safe, effective,
high-quality medicines are developed,
registered, and maintained in the most
resource-efficient manner.
By harmonizing the regulatory
requirements in regions around the
world, ICH guidelines enhance global
drug development, improve
manufacturing standards, and increase
the availability of medications. For
example, ICH guidelines have
substantially reduced duplicative
clinical studies, prevented unnecessary
animal studies, standardized the
reporting of important safety
information, and standardized
marketing application submissions.
The six Founding Members of the ICH
are FDA; the Pharmaceutical Research
and Manufacturers of America; the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labour, and Welfare; and the
Japanese Pharmaceutical Manufacturers
Association. The Standing Members of
the ICH Association include Health
Canada and Swissmedic. ICH
membership continues to expand to
include other regulatory authorities and
industry associations from around the
world (refer to https://www.ich.org/).
ICH works by engaging global
regulatory and industry experts in a
detailed, science-based, and consensusdriven process that results in the
development of ICH guidelines. The
regulators around the world are
committed to consistently adopting
these consensus-based guidelines,
realizing the benefits for patients and for
industry.
As a Founding Regulatory Member of
ICH, FDA plays a major role in the
development of each of the ICH
guidelines, which FDA then adopts and
issues as guidance for industry. FDA’s
guidance documents do not establish
legally enforceable responsibilities.
Instead, they describe the Agency’s
current thinking on a topic and should
be viewed only as recommendations,
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unless specific regulatory or statutory
requirements are cited.
In the Federal Register of October 14,
2021 (86 FR 57159), FDA published a
notice announcing the availability of a
draft guidance entitled ‘‘Q13
Continuous Manufacturing of Drug
Substances and Drug Products.’’ The
notice gave interested persons an
opportunity to submit comments by
December 13, 2021. After consideration
of the comments received and revisions
to the guideline, a final draft of the
guideline was submitted to the ICH
Assembly and endorsed by the
regulatory agencies on November 16,
2022.
This final guidance provides guidance
on the development, implementation,
operation, and life-cycle management of
CM and provides clarification on CM
concepts and describes scientific
approaches and regulatory
considerations specific to CM of drug
substances and drug products. This
guidance also replaces the draft
guidance entitled ‘‘Quality
Considerations for Continuous
Manufacturing,’’ issued on February 27,
2019. Many of the principles in that
guidance have been incorporated in the
guidance entitled ‘‘Q13 Continuous
Manufacturing of Drug Substances and
Drug Products,’’ rendering the 2019
guidance obsolete.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Q13 Continuous
Manufacturing of Drug Substances and
Drug Products.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 relating
to the submissions of investigational
new drug applications have been
approved under OMB control number
0910–0014. The collections of
information in 21 CFR part 314 relating
to the submissions of new drug
applications and abbreviated new drug
applications have been approved under
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OMB control number 0910–0001. The
collections of information in 21 CFR
part 601 relating to the submissions of
biologics license applications have been
approved under OMB control number
0910–0338. The collections of
information in 21 CFR parts 210 and
211 relating to current good
manufacturing practice have been
approved under OMB control number
0910–0139.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances.
Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–04212 Filed 2–28–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0516]
Mylan Pharmaceuticals Inc., et.al.;
Withdrawal of Approval of 11
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 11 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
March 31, 2023.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
SUMMARY:
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Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
§ 314.150(c) is without prejudice to
refiling.
Application No.
Drug
Applicant
ANDA 075980 ......................
Tramadol Hydrochloride (HCl) Tablets, 50 milligrams
(mg).
Tramadol HCl Tablets, 50 mg .........................................
Pirmella 7/7/7 Tablets, 0.035 mg, 0.035 mg, 0.035 mg;
0.5 mg, 0.75 mg, 1 mg.
Mylan Pharmaceuticals Inc., 3711 Collins Ferry Rd.,
Morgantown, WV 26505.
Do.
Lupin Pharmaceuticals, Inc., U.S. Agent for Lupin Ltd.,
111 South Calvert St., Harborplace Tower, 21st
Floor, Baltimore, MD 21202.
Do.
Mylan Pharmaceuticals Inc.
ANDA 075986 ......................
ANDA 201510 ......................
ANDA 201512 ......................
ANDA 203803 ......................
ANDA 203900 ......................
ANDA 203946 ......................
ANDA 205923 ......................
Pirmella 1/35 Tablets, 0.035 mg; 1 mg ..........................
Propafenone HCl, Extended-Release Capsules, 225
mg, 325 mg, and 425 mg.
Tacrolimus Injection, Equivalent to (EQ) 5 mg base/milliliters (mL).
Fludeoxyglucose F18 Injectable, 20–300 millicurie
(mCi)/mL.
Caspofungin Acetate Powder, 50 mg/vial, and 70 mg/
vial.
ANDA 209571 ......................
Darifenacin Hydrobromide Extended-Release Tablets,
EQ 7.5 mg/base and EQ 15 mg/base.
ANDA 211972 ......................
ANDA 213222 ......................
Zileuton Extended-Release Tablets, 600 mg .................
Icatibant Acetate Injectable, EQ 30 mg base/3 mL (EQ
10 mg base/mL).
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of March 31,
2023. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on March 31, 2023
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–04175 Filed 2–28–23; 8:45 am]
BILLING CODE 4164–01–P
ddrumheller on DSK120RN23PROD with NOTICES
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
12943
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Hospira, A Pfizer Company, 275 North Field Dr., Lake
Forest, IL 60045.
Essential Isotopes, LLC, 1513 Research Park Dr., Columbia, MO 65211.
Xellia Pharmaceuticals USA, LLC, U.S. Agent for Xellia
Pharmaceuticals ApS, 2150 East Lake Cook Rd.,
Suite 1015, Buffalo Grove, IL 60089.
Xiromed, LLC., U.S. Agent for Xiromed Pharma
Espan˜a, S.L., 180 Park Ave., Suite 101, Florham
Park, NJ 07932.
Lupin Pharmaceuticals, Inc.
Glenmark Pharmaceuticals Inc., USA, U.S. Agent for
Glenmark Pharmaceuticals Ltd., 750 Corporate Dr.,
Mahwah, NJ 07430.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0487]
Discussion Paper: Artificial
Intelligence in Drug Manufacturing,
Notice; Request for Information and
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for information
and comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing publication of a discussion
paper providing information for
stakeholders and soliciting public
comments on a specific area of emerging
and advanced manufacturing
technologies. The discussion paper
presents areas for consideration and
policy development identified by the
Center for Drug Evaluation and Research
(CDER) scientific and policy experts
associated with application of artificial
intelligence (AI) to pharmaceutical
manufacturing. The discussion paper
includes a series of questions to
stimulate feedback from the public,
including CDER and the Center for
Biologics Evaluation and Research
(CBER) stakeholders.
SUMMARY:
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Submit either written or
electronic comments and information by
May 1, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 1, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
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]]>Agencies
[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Pages 12942-12943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04175]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0516]
Mylan Pharmaceuticals Inc., et.al.; Withdrawal of Approval of 11
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 11 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.
DATES: Approval is withdrawn as of March 31, 2023.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
[[Page 12943]]
requested that FDA withdraw approval of the applications under the
process described in Sec. 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 075980................. Tramadol Mylan
Hydrochloride (HCl) Pharmaceuticals
Tablets, 50 Inc., 3711 Collins
milligrams (mg). Ferry Rd.,
Morgantown, WV
26505.
ANDA 075986................. Tramadol HCl Do.
Tablets, 50 mg.
ANDA 201510................. Pirmella 7/7/7 Lupin
Tablets, 0.035 mg, Pharmaceuticals,
0.035 mg, 0.035 mg; Inc., U.S. Agent
0.5 mg, 0.75 mg, 1 for Lupin Ltd., 111
mg. South Calvert St.,
Harborplace Tower,
21st Floor,
Baltimore, MD
21202.
ANDA 201512................. Pirmella 1/35 Do.
Tablets, 0.035 mg;
1 mg.
ANDA 203803................. Propafenone HCl, Mylan
Extended-Release Pharmaceuticals
Capsules, 225 mg, Inc.
325 mg, and 425 mg.
ANDA 203900................. Tacrolimus Hospira, A Pfizer
Injection, Company, 275 North
Equivalent to (EQ) Field Dr., Lake
5 mg base/ Forest, IL 60045.
milliliters (mL).
ANDA 203946................. Fludeoxyglucose F18 Essential Isotopes,
Injectable, 20-300 LLC, 1513 Research
millicurie (mCi)/mL. Park Dr., Columbia,
MO 65211.
ANDA 205923................. Caspofungin Acetate Xellia
Powder, 50 mg/vial, Pharmaceuticals
and 70 mg/vial. USA, LLC, U.S.
Agent for Xellia
Pharmaceuticals
ApS, 2150 East Lake
Cook Rd., Suite
1015, Buffalo
Grove, IL 60089.
ANDA 209571................. Darifenacin Xiromed, LLC., U.S.
Hydrobromide Agent for Xiromed
Extended-Release Pharma
Tablets, EQ 7.5 mg/ Espa[ntilde]a,
base and EQ 15 mg/ S.L., 180 Park
base. Ave., Suite 101,
Florham Park, NJ
07932.
ANDA 211972................. Zileuton Extended- Lupin
Release Tablets, Pharmaceuticals,
600 mg. Inc.
ANDA 213222................. Icatibant Acetate Glenmark
Injectable, EQ 30 Pharmaceuticals
mg base/3 mL (EQ 10 Inc., USA, U.S.
mg base/mL). Agent for Glenmark
Pharmaceuticals
Ltd., 750 Corporate
Dr., Mahwah, NJ
07430.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
31, 2023. Approval of each entire application is withdrawn, including
any strengths and dosage forms inadvertently missing from the table.
Introduction or delivery for introduction into interstate commerce of
products without approved new drug applications violates section 301(a)
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in the table that are in
inventory on March 31, 2023 may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.
Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04175 Filed 2-28-23; 8:45 am]
BILLING CODE 4164-01-P
