Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications, 16271-16272 [2023-05360]
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Federal Register / Vol. 88, No. 51 / Thursday, March 16, 2023 / Notices
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Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05359 Filed 3–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0722]
Fresenius Kabi USA, LLC, et al.;
Withdrawal of Approval of Six
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\16MRN1.SGM
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16272
ACTION:
Federal Register / Vol. 88, No. 51 / Thursday, March 16, 2023 / Notices
Notice.
Approval is withdrawn as of
April 17, 2023.
DATES:
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of six 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applications be withdrawn.
SUMMARY:
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.
The
applicants listed in the table have
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 065111 ...........................
Kanamycin Sulfate Injection, Equivalent to
(EQ) 500 milligrams (mg) base/2 milliliters
(mL) and EQ 1 gram (g) base/3 mL.
Levetiracetam Solution, 100 mg/mL ................
Nimodipine Capsules, 30 mg ...........................
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
ANDA 079107 ...........................
ANDA 201832 ...........................
ANDA 202418 ...........................
Lamivudine and Zidovudine Tablets, 150 mg;
300 mg.
ANDA 202743 ...........................
Azelastine Hydrochloride (HCl), Metered
Spray, 0.2055 mg/spray.
ANDA 203937 ...........................
Fludeoxyglucose F18 Injection, 4–500 millicurie (mCi)/mL.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of April 17,
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application is withdrawn, including any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 April 17, 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: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05360 Filed 3–15–23; 8:45 am]
BILLING CODE 4164–01–P
ddrumheller on DSK120RN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
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 § 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
§ 314.150(c) is without prejudice to
refiling.
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Tolmar, Inc., 701 Centre Ave., Fort Collins, CO 80526.
Sofgen Pharmaceuticals, LCC, 21500 Biscayne Blvd., Suite
600, Aventura, FL 33180.
Aurobindo Pharma USA, Inc., U.S. Agent for Aurobindo
Pharma Ltd., 279 Princeton-Hightstown Rd., East Windsor,
NJ 08520.
Padagis US LLC., U.S. Agent for Padagis Israel Pharmaceuticals Ltd. (formerly known as Perrigo Israel Pharmaceuticals Ltd.), 3940 Quebec Avenue North, Minneapolis,
MN 55427.
Hot Shots NM, LLC, DBA Midwest Positron Technology, LC,
2017 E Kimberly Rd., Suite C, Davenport IA 52807.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0583]
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]]>Agencies
[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16271-16272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05360]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0722]
Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Six
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
[[Page 16272]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of six 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 April 17, 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
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 065111................... Kanamycin Sulfate Fresenius Kabi USA,
Injection, LLC, Three Corporate
Equivalent to Dr., Lake Zurich, IL
(EQ) 500 60047.
milligrams (mg)
base/2
milliliters (mL)
and EQ 1 gram
(g) base/3 mL.
ANDA 079107................... Levetiracetam Tolmar, Inc., 701
Solution, 100 mg/ Centre Ave., Fort
mL. Collins, CO 80526.
ANDA 201832................... Nimodipine Sofgen
Capsules, 30 mg. Pharmaceuticals,
LCC, 21500 Biscayne
Blvd., Suite 600,
Aventura, FL 33180.
ANDA 202418................... Lamivudine and Aurobindo Pharma USA,
Zidovudine Inc., U.S. Agent for
Tablets, 150 mg; Aurobindo Pharma
300 mg. Ltd., 279 Princeton-
Hightstown Rd., East
Windsor, NJ 08520.
ANDA 202743................... Azelastine Padagis US LLC., U.S.
Hydrochloride Agent for Padagis
(HCl), Metered Israel
Spray, 0.2055 mg/ Pharmaceuticals Ltd.
spray. (formerly known as
Perrigo Israel
Pharmaceuticals
Ltd.), 3940 Quebec
Avenue North,
Minneapolis, MN
55427.
ANDA 203937................... Fludeoxyglucose Hot Shots NM, LLC,
F18 Injection, 4- DBA Midwest Positron
500 millicurie Technology, LC, 2017
(mCi)/mL. E Kimberly Rd.,
Suite C, Davenport
IA 52807.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of April
17, 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 April 17, 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: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05360 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P
