Fresenius Kabi USA, LLC, et. al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications, 38158-38159 [2024-09914]
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38158
Federal Register / Vol. 89, No. 89 / Tuesday, May 7, 2024 / Notices
The reorganization retitled OCE as the
Office of Communication, Information
Disclosure, Training, and Education
(OCITE); abolished the Digital
Communication Media Staff; established
the Office of Communication and
Content Development (OCCD) and the
Office of Training and Education (OTE)
within OCITE, established the Division
of Digital Communication and
Marketing (DDCM) within OCCD, and
realigned the existing divisions to the
new offices.
DCCE. ORGANIZATION. CDRH’s
OCITE is headed by the Director, and
includes the following:
Office of Communication, Information
Disclosure, Training, and Education
(DCCE)
Program Management Operations Staff
(DCCE1)
Office of Communication and Content
Development (DCCEE)
Division of Communication (DCCEEA)
Division of Information Disclosure
(DCCEEB)
Division of Digital Communication and
Marketing (DCCEEC)
Office of Training and Education
(DCCEF)
Division of Employee Training and
Development (DCCEFA)
Division of Industry and Consumer
Education (DCCEFB)
II. Delegations of Authority
Pending further delegation, directives,
or orders by the Commissioner of Food
and Drugs, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Electronic Access
This reorganization is reflected in
FDA’s Staff Manual Guide (SMG).
Persons interested in seeing the
complete SMG can find it on FDA’s
website at: https://www.fda.gov/
AboutFDA/ReportsManualsForms/Staff
ManualGuides/default.htm.
(Authority: 44 U.S.C. 3101).
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2024–09381 Filed 5–6–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA), Center for
Devices and Radiological Health’s
(CDRH), Office of Product Evaluation
and Quality (OPEQ) has modified their
organizational structure. The new
organizational structure was approved
by the Secretary of Health and Human
Services on December 21, 2023, and it
became effective on January 22, 2024.
FOR FURTHER INFORMATION CONTACT:
Yashika Rahaman, Director, Office of
Planning, Evaluation and Risk
Management, Office of Finance, Budget,
Acquisitions and Planning, Food and
Drug Administration, 4041 Powder Mill
Rd., Beltsville, MD 20705–4304, 301–
796–3843.
SUMMARY:
I. Introduction
Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970, 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August
18, 2009, 76 FR 45270, July 28, 2011,
and 84 FR 22854, May 20, 2019) is
amended to reflect the reorganization of
the CDRH OCE.
The reorganization of OPEQ impacted
the OPEQ’s Office of Clinical Evidence
and Analysis (OCEA) and the OPEQ’s
Office of Health Technology IV (OHT
IV). OCEA established the Division of
Clinical Evidence and Analysis IV and
the Division of Clinical Evidence and
Analysis V. OHT IV established the
Division of Health Technology IV C.
DCCFB. ORGANIZATION. CDRH’s
OPEQ OCEA is headed by the Director,
and includes the following:
Office of Clinical Evidence and Analysis
(DCCFB)
Division of Clinical Evidence and
Analysis I (DCCFBA)
Division of Clinical Evidence and
Analysis II (DCCFBB)
Division of Clinical Evidence and
Analysis III (DCCFBC)
Division of Clinical Evidence and
Analysis IV (DCCFBD)
Division of Clinical Evidence and
Analysis V (DCCFBE)
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DCCFF. ORGANIZATION. CDRH’s
OPEQ OHT IV is headed by the Director,
and includes the following:
Office of Health Technology IV (DCCFF)
Division of Health Technology IV A
(DCCFFA)
Division of Health Technology IV B
(DCCFFB)
Division of Health Technology IV C
(DCCFFC)
II. Delegations of Authority
Pending further delegation, directives,
or orders by the Commissioner of Food
and Drugs, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
III. Electronic Access
This reorganization is reflected in
FDA’s Staff Manual Guide (SMG).
Persons interested in seeing the
complete SMG can find it on FDA’s
website at: https://www.fda.gov/
AboutFDA/ReportsManualsForms/Staff
ManualGuides/default.htm.
(Authority: 44 U.S.C. 3101).
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2024–09382 Filed 5–6–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1917]
Fresenius Kabi USA, LLC, et. al.;
Withdrawal of Approval of 12
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 12 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
June 6, 2024.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
SUMMARY:
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Federal Register / Vol. 89, No. 89 / Tuesday, May 7, 2024 / Notices
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
Drug
ANDA 040379 ......
Fluorouracil Injectable, 50 milligrams (mg)/milliliter (mL) ........................
ANDA 062901 ......
ANDA 071981 ......
Ampicillin Sodium; Sulbactam Sodium Injectable, Equivalent to (EQ) 2
grams (gm) base/vial; EQ 1 gm base/vial, and EQ 1 gm base/vial;
EQ 500 mg base/vial.
Droperidol Injectable, 2.5 mg/mL .............................................................
ANDA 202546 ......
Ribavirin Tablets, 200 mg, 400 mg, 500 mg, and 600 mg ......................
ANDA 203544 ......
Sodium Fluoride F–18 Injectable, 10–200 millicurie (mCi)/mL ................
ANDA 203773 ......
ANDA 203884 ......
ANDA 204315 ......
Dexmedetomidine Hydrochloride (HCl) Injectable, EQ 200 microgram
(mcg) base/2 mL (EQ 100 mcg base/mL).
Amiodarone HCl Injectable, 50 mg/mL ....................................................
Sodium Fluoride F–18 Injectable, 10–200 mCi/mL .................................
ANDA 204366 ......
ANDA 204854 ......
Ammonia N 13 Injectable, 3.75–260 mCi/mL ..........................................
Meropenem for Injection, 500 mg/vial and 1 gm/vial ...............................
ANDA 206710 ......
Paricalcitol Capsules, 1 mcg, 2 mcg, and 4 mcg ....................................
ANDA 208695 ......
Bosentan Tablets, 62.5 mg, and 125 mg ................................................
khammond on DSKJM1Z7X2PROD with NOTICES
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of June 6, 2024.
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 listed in the table
without an approved new drug
application or ANDA violates sections
505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)). Drug products that
are listed in the table that are in
inventory on June 6, 2024 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: May 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–09914 Filed 5–6–24; 8:45 am]
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opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
are no longer marketed and have
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,
by their requests, waived their
Application No.
Applicant
Fresenius Kabi USA, LLC, Three Corporate Dr.,
Lake Zurich, IL 60047.
Pfizer Inc., 66 Hudson Blvd East, New York, NY
10001.
Hospira Inc., 275 North Field Dr., Bldg. H1–3S,
Lake Forest, IL 60045.
RegCon Solutions, LLC, U.S. Agent for Beximco
Pharmaceuticals USA Inc., 10525 Vista Sorrento Parkway, Suite 100, San Diego, CA
92121.
SOFIE Co. dba SOFIE, 21000 Atlantic Blvd.,
Suite 730, Dulles, VA 20166.
American Regent, Inc., 5 Ramsey Rd., Shirley,
NY 11967.
Hospira Inc.
B&H Consulting Services, Inc., U.S. Agent for
Shertech Laboratories, LLC, 50 Division St.,
Suite 206, Somerville, NJ 08876.
Do.
Freyr Inc., U.S. Agent for Daewoong Pharmaceutical Co., Ltd., 150 College Rd. West, Suite
102, Princeton, NJ 08540.
Alvogen PB Research and Development LLC,
U.S. Agent for Lotus Pharmaceutical Co., Ltd.
Nantou Plant, 44 Whippany Rd., Suite 300,
Morristown, NJ 07960.
Hikma Pharmaceuticals USA Inc., 1809 Wilson
Rd., Columbus, OH 43228.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3827]
Adam Paul Runsdorf: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) permanently
debarring Adam Paul Runsdorf from
providing services in any capacity to a
person that has an approved or pending
drug product application. FDA bases
this order on a finding that Mr.
Runsdorf was convicted of a felony
under Federal law for conduct that
relates to the regulation of a drug
product under the FD&C Act. Mr.
Runsdorf was given notice of the
proposed debarment and an opportunity
to request a hearing within the
timeframe prescribed by regulation. As
of February 25, 2024 (30 days after
SUMMARY:
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38159
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receipt of the notice), Mr. Runsdorf has
not responded. Mr. Runsdorf’s failure to
respond and request a hearing
constitutes a waiver of Mr. Runsdorf’s
right to a hearing concerning this
matter.
DATES:
This order is applicable May 7,
2024.
Any application by Mr.
Runsdorf for special termination of
debarment under section 306(d)(4) of
the FD&C Act (21 U.S.C. 335a(d)(4)) may
be submitted at any time as follows:
ADDRESSES:
Electronic Submissions
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
application will be made public, you are
solely responsible for ensuring that your
application 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
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]]>Agencies
[Federal Register Volume 89, Number 89 (Tuesday, May 7, 2024)]
[Notices]
[Pages 38158-38159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09914]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1917]
Fresenius Kabi USA, LLC, et. al.; Withdrawal of Approval of 12
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 12 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 June 6, 2024.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
[[Page 38159]]
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
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 040379............... Fluorouracil Injectable, Fresenius Kabi
50 milligrams (mg)/ USA, LLC, Three
milliliter (mL). Corporate Dr.,
Lake Zurich, IL
60047.
ANDA 062901............... Ampicillin Sodium; Pfizer Inc., 66
Sulbactam Sodium Hudson Blvd East,
Injectable, Equivalent New York, NY
to (EQ) 2 grams (gm) 10001.
base/vial; EQ 1 gm base/
vial, and EQ 1 gm base/
vial; EQ 500 mg base/
vial.
ANDA 071981............... Droperidol Injectable, Hospira Inc., 275
2.5 mg/mL. North Field Dr.,
Bldg. H1-3S, Lake
Forest, IL 60045.
ANDA 202546............... Ribavirin Tablets, 200 RegCon Solutions,
mg, 400 mg, 500 mg, and LLC, U.S. Agent
600 mg. for Beximco
Pharmaceuticals
USA Inc., 10525
Vista Sorrento
Parkway, Suite
100, San Diego,
CA 92121.
ANDA 203544............... Sodium Fluoride F-18 SOFIE Co. dba
Injectable, 10-200 SOFIE, 21000
millicurie (mCi)/mL. Atlantic Blvd.,
Suite 730,
Dulles, VA 20166.
ANDA 203773............... Dexmedetomidine American Regent,
Hydrochloride (HCl) Inc., 5 Ramsey
Injectable, EQ 200 Rd., Shirley, NY
microgram (mcg) base/2 11967.
mL (EQ 100 mcg base/mL).
ANDA 203884............... Amiodarone HCl Hospira Inc.
Injectable, 50 mg/mL.
ANDA 204315............... Sodium Fluoride F-18 B&H Consulting
Injectable, 10-200 mCi/ Services, Inc.,
mL. U.S. Agent for
Shertech
Laboratories,
LLC, 50 Division
St., Suite 206,
Somerville, NJ
08876.
ANDA 204366............... Ammonia N 13 Injectable, Do.
3.75-260 mCi/mL.
ANDA 204854............... Meropenem for Injection, Freyr Inc., U.S.
500 mg/vial and 1 gm/ Agent for
vial. Daewoong
Pharmaceutical
Co., Ltd., 150
College Rd. West,
Suite 102,
Princeton, NJ
08540.
ANDA 206710............... Paricalcitol Capsules, 1 Alvogen PB
mcg, 2 mcg, and 4 mcg. Research and
Development LLC,
U.S. Agent for
Lotus
Pharmaceutical
Co., Ltd. Nantou
Plant, 44
Whippany Rd.,
Suite 300,
Morristown, NJ
07960.
ANDA 208695............... Bosentan Tablets, 62.5 Hikma
mg, and 125 mg. Pharmaceuticals
USA Inc., 1809
Wilson Rd.,
Columbus, OH
43228.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of June
6, 2024. 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 listed in the table without an approved new drug application
or ANDA violates sections 505(a) and 301(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are
listed in the table that are in inventory on June 6, 2024 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: May 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09914 Filed 5-6-24; 8:45 am]
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