Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications, 87787 [2023-27853]
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Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices
contentions concerning his debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Jeremy
Walenty has been convicted of a felony
under Federal law for conduct relating
to the importation into the United States
of any drug or controlled substance.
FDA finds that the offense should be
accorded a debarment period of 5 years
as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding,
Mr. Walenty is debarred for a period of
5 years from importing or offering for
import any drug into the United States,
effective (see DATES). Pursuant to section
301(cc) of the FD&C Act (21 U.S.C.
331(cc)), the importing or offering for
import into the United States of any
drug by, with the assistance of, or at the
direction of Mr. Walenty is a prohibited
act.
approval of the applications be
withdrawn.
[FR Doc. 2023–27855 Filed 12–18–23; 8:45 am]
BILLING CODE 4164–01–P
Approval is withdrawn as of
January 18, 2024.
DATES:
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5431]
Hospira, Inc., et al.; Withdrawal of
Approval of Eight Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
withdrawing approval of eight
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
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
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 the
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 063081 ........
Hospira, Inc., 275 North Field Dr., Building H1–3S, Lake
Forest, IL 60045.
ANDA 080629 ........
Tobramycin Sulfate, Injectable, Equivalent to (EQ) 1.2 milligrams (mg) base/milliliters (mL), EQ 1.6 mg base/mL, EQ
80 mg base/100 mL.
Tobramycin Sulfate, Injection, EQ 10 mg base/mL ...............
Fentanyl Citrate, Troche/Lozenges, EQ 0.2 mg base, EQ
0.4 mg base, EQ 0.6 mg base, EQ 0.8 mg base, EQ 1.2
mg base, EQ 1.6 mg base.
Promethazine Hydrochloride (HCl), Injectable, 50 mg/mL ....
ANDA 091170 ........
Zoledronic Acid, Injectable, EQ 4 mg base/5 mL ..................
ANDA 201846 ........
Azelastine HCl, Metered Spray, 0.2055 mg/spray .................
ANDA 207698 ........
Nevirapine Extended-Release Tablets, 400 mg ....................
ANDA 208616 ........
Nevirapine Extended-Release Tablets, 100 mg ....................
ANDA 063112 ........
ANDA 078907 ........
lotter on DSK11XQN23PROD with NOTICES1
Dated: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
87787
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 18,
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 January 18, 2024 may
continue to be dispensed until the
VerDate Sep<11>2014
17:33 Dec 18, 2023
Jkt 262001
Do.
SpecGx LLC, 385 Marshall Ave., Webster Groves, MO
63119.
Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace
Parkway, Building A, Parsippany, NJ 07054.
Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite
201, Berlin, CT 06037.
Apotex Corp, U.S. Agent for Apotex Inc., 2400 North Commerce Parkway, Suite 400, Weston, FL 33326.
Aurobindo Pharma USA, Inc., U.S. Agent for Aurobindo
Pharma Limited, 279 Princeton-Hightstown Rd., East
Windsor, NJ 08520.
Do.
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[Docket No. FDA–2009–N–0026]
[FR Doc. 2023–27853 Filed 12–18–23; 8:45 am]
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PO 00000
Food and Drug Administration
Apothecon, et al.; Withdrawal of
Approval of 103 New Drug
Applications and 35 Abbreviated New
Drug Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on February 11, 2009. The
SUMMARY:
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]]>Agencies
[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Page 87787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27853]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5431]
Hospira, Inc., et al.; Withdrawal of Approval of Eight
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing approval of eight 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 January 18, 2024.
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 the 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 063081............. Tobramycin Sulfate, Hospira, Inc., 275
Injectable, North Field Dr.,
Equivalent to (EQ) Building H1-3S, Lake
1.2 milligrams (mg) Forest, IL 60045.
base/milliliters
(mL), EQ 1.6 mg base/
mL, EQ 80 mg base/100
mL.
ANDA 063112............. Tobramycin Sulfate, Do.
Injection, EQ 10 mg
base/mL.
ANDA 078907............. Fentanyl Citrate, SpecGx LLC, 385
Troche/Lozenges, EQ Marshall Ave.,
0.2 mg base, EQ 0.4 Webster Groves, MO
mg base, EQ 0.6 mg 63119.
base, EQ 0.8 mg base,
EQ 1.2 mg base, EQ
1.6 mg base.
ANDA 080629............. Promethazine Watson Laboratories,
Hydrochloride (HCl), Inc. (an indirect,
Injectable, 50 mg/mL. wholly owned
subsidiary of Teva
Pharmaceuticals USA,
Inc.), 400 Interpace
Parkway, Building A,
Parsippany, NJ 07054.
ANDA 091170............. Zoledronic Acid, Breckenridge
Injectable, EQ 4 mg Pharmaceutical, Inc.,
base/5 mL. 15 Massirio Dr.,
Suite 201, Berlin, CT
06037.
ANDA 201846............. Azelastine HCl, Apotex Corp, U.S.
Metered Spray, 0.2055 Agent for Apotex
mg/spray. Inc., 2400 North
Commerce Parkway,
Suite 400, Weston, FL
33326.
ANDA 207698............. Nevirapine Extended- Aurobindo Pharma USA,
Release Tablets, 400 Inc., U.S. Agent for
mg. Aurobindo Pharma
Limited, 279
Princeton-Hightstown
Rd., East Windsor, NJ
08520.
ANDA 208616............. Nevirapine Extended- Do.
Release Tablets, 100
mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 18, 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 January
18, 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: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27853 Filed 12-18-23; 8:45 am]
BILLING CODE 4164-01-P
