Hospira, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications, 10177 [2020-03512]
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Federal Register / Vol. 85, No. 35 / Friday, February 21, 2020 / Notices
Our estimated burden for the
information collection reflects an
overall increase of 40 hours and a
corresponding increase of one response/
record. We attribute this adjustment to
an increase in the number of
submissions we received over the last
few years.
Dated: February 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03459 Filed 2–20–20; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–6083]
Hospira, Inc., et al.; Withdrawal of
Approval of 15 Abbreviated New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
BILLING CODE 4164–01–P
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 15 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applications be withdrawn.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:
Approval is withdrawn as of
March 23, 2020.
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
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.
DATES:
Application No.
Drug
Applicant
ANDA 040372 .........
Promethazine Hydrochloride (HCl) Injection, 25 milligrams
(mg)/milliliter (mL) and 50 mg/mL.
Cephalexin Capsules, Equivalent to (EQ) 250 mg base and
500 mg base.
Cefazolin Sodium for Injection, EQ 500 mg base/vial and
EQ 1 gram (g) base/vial.
Cefazolin Sodium for Injection, EQ 1 g base/vial .................
Cefotetan Disodium for Injection, EQ 10 g base/vial ............
Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL
60045.
Sun Pharmaceutical Industries, Inc., 2 Independence Way,
Princeton, NJ 08540.
Hospira, Inc.
ANDA 062791 .........
ANDA 065226 .........
ANDA 065244 .........
ANDA 065375 .........
ANDA 065386 .........
ANDA 065446 .........
ANDA 075955 .........
ANDA 076124 .........
ANDA 076722 .........
ANDA 080700 .........
ANDA 083201 .........
ANDA 201654 .........
ANDA 203950 .........
ANDA 207731 .........
khammond on DSKJM1Z7X2PROD with NOTICES
10177
Piperacillin Sodium and Tazobactam Sodium for Injection,
EQ 2 g base/vial; EQ 250 mg base/vial, EQ 3 g base/
vial; EQ 375 mg base/vial, EQ 4 g base/vial; EQ 500 mg
base/vial.
Piperacillin Sodium and Tazobactam Sodium for Injection,
EQ 36 g base/vial; EQ 4.5 g base/vial.
Amiodarone HCl Injection, 50 mg/mL ...................................
Ranitidine HCl Syrup, EQ 15 mg base/mL ...........................
Ketorolac Tromethamine Injection, 15 mg/mL, 30 mg/mL,
and 60 mg/mL.
Chlorpheniramine Maleate Tablets, 4 mg .............................
Hydrocortisone Lotion, 1% ....................................................
Cefazolin Sodium for Injection, EQ 1 g base/vial .................
Oxacillin Sodium for Injection, EQ 1 g base/vial and EQ 2 g
base/vial.
Nystatin and Triamcinolone Acetonide Ointment, 100,000
units/g; 0.1%.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of March 23,
2020. Approval of each entire
application is withdrawn, including any
strengths or products inadvertently
missing from the table. Introduction or
delivery for introduction into interstate
VerDate Sep<11>2014
17:22 Feb 20, 2020
Jkt 250001
Do.
Fresenius Kabi USA, LLC., Three Corporate Dr., Lake Zurich, IL 60047.
Hospira, Inc.
Do.
Do.
Actavis Mid Atlantic, LLC., Subsidiary of Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Morris Corporate Center III, Bldg. A, Third Floor, Parsippany, NJ
07054.
INC Research, LLC., 4800 Falls of Neuse Rd., Suite 600,
Raleigh, NC 27609.
Sun Pharmaceutical Industries, Inc.
Crown Laboratories, Inc., 349 Lafe Cox Dr., Johnson City,
TN 37604.
Hospira, Inc.
Do.
Crown Laboratories, Inc.
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 23, 2020 may
continue to be dispensed until the
inventories have been depleted or the
PO 00000
Frm 00031
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drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: February 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03512 Filed 2–20–20; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\21FEN1.SGM
21FEN1
]]>Agencies
[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Notices]
[Page 10177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03512]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-6083]
Hospira, Inc., et al.; Withdrawal of Approval of 15 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 15 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 23, 2020.
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 040372............... Promethazine Hospira, Inc., 275
Hydrochloride (HCl) North Field Dr.,
Injection, 25 Bldg. H1, Lake
milligrams (mg)/ Forest, IL 60045.
milliliter (mL) and
50 mg/mL.
ANDA 062791............... Cephalexin Capsules, Sun Pharmaceutical
Equivalent to (EQ) Industries, Inc., 2
250 mg base and 500 Independence Way,
mg base. Princeton, NJ 08540.
ANDA 065226............... Cefazolin Sodium for Hospira, Inc.
Injection, EQ 500 mg
base/vial and EQ 1
gram (g) base/vial.
ANDA 065244............... Cefazolin Sodium for Do.
Injection, EQ 1 g
base/vial.
ANDA 065375............... Cefotetan Disodium Fresenius Kabi USA,
for Injection, EQ 10 LLC., Three
g base/vial. Corporate Dr., Lake
Zurich, IL 60047.
ANDA 065386............... Piperacillin Sodium Hospira, Inc.
and Tazobactam
Sodium for
Injection, EQ 2 g
base/vial; EQ 250 mg
base/vial, EQ 3 g
base/vial; EQ 375 mg
base/vial, EQ 4 g
base/vial; EQ 500 mg
base/vial.
ANDA 065446............... Piperacillin Sodium Do.
and Tazobactam
Sodium for
Injection, EQ 36 g
base/vial; EQ 4.5 g
base/vial.
ANDA 075955............... Amiodarone HCl Do.
Injection, 50 mg/mL.
ANDA 076124............... Ranitidine HCl Syrup, Actavis Mid Atlantic,
EQ 15 mg base/mL. LLC., Subsidiary of
Teva Pharmaceuticals
USA, Inc., 400
Interpace Pkwy.,
Morris Corporate
Center III, Bldg. A,
Third Floor,
Parsippany, NJ
07054.
ANDA 076722............... Ketorolac INC Research, LLC.,
Tromethamine 4800 Falls of Neuse
Injection, 15 mg/mL, Rd., Suite 600,
30 mg/mL, and 60 mg/ Raleigh, NC 27609.
mL.
ANDA 080700............... Chlorpheniramine Sun Pharmaceutical
Maleate Tablets, 4 Industries, Inc.
mg.
ANDA 083201............... Hydrocortisone Crown Laboratories,
Lotion, 1%. Inc., 349 Lafe Cox
Dr., Johnson City,
TN 37604.
ANDA 201654............... Cefazolin Sodium for Hospira, Inc.
Injection, EQ 1 g
base/vial.
ANDA 203950............... Oxacillin Sodium for Do.
Injection, EQ 1 g
base/vial and EQ 2 g
base/vial.
ANDA 207731............... Nystatin and Crown Laboratories,
Triamcinolone Inc.
Acetonide Ointment,
100,000 units/g;
0.1%.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
23, 2020. Approval of each entire application is withdrawn, including
any strengths or products 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 23, 2020 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 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03512 Filed 2-20-20; 8:45 am]
BILLING CODE 4164-01-P
