Wockhardt Limited, et al.; Withdrawal of Approval of 28 Abbreviated New Drug Applications, 8598-8599 [2020-03025]
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Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Notices
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FOR FURTHER INFORMATION CONTACT:
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Evaluation and Research, Office of New
Drugs, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22,
Rm. 6373, Silver Spring, MD, 20993,
301–796–8828; Irene Chan, Center for
Drug Evaluation and Research, Office of
New Drugs, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4420, Silver Spring,
MD, 20993, 301–796–3962; Stephen
Ripley, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
In the
Federal Register of December 19, 2019,
FDA published a notice of availability
with a 60-day comment period to
request comments on the draft guidance
for industry entitled ‘‘Bridging for DrugDevice and Biologic-Device
Combination Products.’’
The Agency has received requests for
an extension of the comment period for
the notice of availability. Each request
conveyed concern that the current 60day comment period does not allow
sufficient time to develop a meaningful
or thoughtful response to the notice of
availability. FDA has considered the
requests and is extending the comment
period for the notice of availability for
60 days, until April 20, 2020. The
Agency believes that a 60-day extension
allows adequate time for interested
persons to submit comments without
compromising the timely publication of
the final version of the guidance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5608]
Wockhardt Limited, et al.; Withdrawal
of Approval of 28 Abbreviated New
Drug Applications
AGENCY:
ACTION:
SUPPLEMENTARY INFORMATION:
Dated: February 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03023 Filed 2–13–20; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 28 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applications be withdrawn.
DATES: Approval is withdrawn as of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 16, 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.
SUMMARY:
Application
No.
Drug
Applicant
ANDA 040732 ..
Phenytoin Sodium Capsules, 100 milligrams (mg) (Extended)
ANDA 065230 ..
Ceftriaxone for Injection, Equivalent to (EQ) 250 mg base/
vial; EQ 500 mg base/vial; EQ 1 gram (g) base/vial; EQ 2 g
base/vial.
Ceftriaxone for Injection, EQ 1 g base/vial; EQ 2 g base/vial
Piggy Back.
Cefotaxime Sodium for Injection, EQ 500 mg base/vial; EQ 1
g base/vial; EQ 2 g base/vial.
Cefotaxime Sodium for Injection, EQ 10 g base/vial Pharmacy Bulk Package.
Cefotaxime Sodium for Injection, EQ 1 g base/vial; EQ 2 g
base/vial.
Cefoxitin for Injection, EQ 10 g base/vial Pharmacy Bulk
Package.
Cefoxitin for Injection, EQ 1 g base/vial; EQ 2 g base/vial ......
Cefepime Hydrochloride (HCl) for Injection, EQ 500 mg base/
vial; EQ 1 g base/vial; EQ 2 g base/vial.
Cefuroxime Sodium for Injection, EQ 750 mg base/vial; EQ
1.5 g base/vial.
Wockhardt Limited, c/o Morton Grove Pharmaceuticals, Inc.,
6451 Main St., Morton Grove, IL 60053.
Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL
60045.
ANDA 065231 ..
ANDA 065290 ..
ANDA 065292 ..
khammond on DSKJM1Z7X2PROD with NOTICES
MD 20993–0002, 240–402–7911;
Andrew Yeatts, Center for Devices and
Radiological Health, Food and Drug
Administration 10903 New Hampshire
Ave., Bldg. 66, Rm. 5452, Silver Spring,
MD 20993–0002, 301–796–4539; or
Patricia Love, Office of Special Medical
Programs, Office of Combination
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5144, Silver Spring,
MD 20993–0002, 301–796–8933.
ANDA 065293 ..
ANDA 065312 ..
ANDA 065313 ..
ANDA 065369 ..
ANDA 065483 ..
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Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Notices
Application
No.
Drug
ANDA 065484 ..
ANDA 204879 ..
Cefuroxime Sodium for Injection, EQ 7.5 g base/vial Pharmacy Bulk Package.
Cefuroxime Sodium for Injection, EQ 1.5 g base/vial ..............
Prednisolone Sodium Phosphate Oral Solution, EQ 15 mg
base/5 milliliters (mL).
Acetaminophen, Butalbital, Caffeine, and Codeine Phosphate
Capsules, 325 mg, 50 mg, 40 mg, and 30 mg.
Ampicillin and Sulbactam for Injection, EQ 1 g base/vial and
EQ 500 mg base/vial; EQ 2 g base/vial and EQ 1 g base/
vial.
Ampicillin and Sulbactam for Injection, EQ 10 g base/vial and
EQ 5 g base/vial.
Ampicillin and Sulbactam for Injection, EQ 1 g base/vial and
EQ 500 mg base/vial; EQ 2 g base/vial and EQ 1 g base/
vial.
Imipenem and Cilastatin for Injection, EQ 250 mg base/vial
and 250 mg base/vial; EQ 500 mg base/vial and 500 mg/
vial.
Meropenem for Injection, 500 mg/vial, and 1 g/vial .................
Imipenem and Cilastatin for Injection, EQ 500 mg base/vial
and 500 mg/vial.
Cefepime HCl for Injection, EQ 1 g base/vial; EQ 2 g base/
vial.
Ceftriaxone for Injection, EQ 1 g base/vial; EQ 2 g base/vial ..
Ampicillin Sodium for Injection, EQ 250 mg base/vial; EQ 500
mg base/vial; EQ 1 g base/vial; EQ 2 g base/vial.
Ampicillin Sodium for Injection, EQ 10 g base/vial Pharmacy
Bulk Package.
Cefotaxime Sodium for Injection, EQ 1 g base/vial; EQ 2 g
base/vial.
Pyridoxine HCl Injection, 100 mg/mL .......................................
ANDA 206062 ..
Doxorubicin HCl for Injection, USP, 20 mg/vial ........................
ANDA 206195 ..
Daunorubicin HCl for Injection, EQ 20 mg base/vial ................
ANDA 065503 ..
ANDA 075250 ..
ANDA 075618 ..
ANDA 090375 ..
ANDA 090646 ..
ANDA 090653 ..
ANDA 090825 ..
ANDA 090940 ..
ANDA 091007 ..
ANDA 202268 ..
ANDA 202563 ..
ANDA 202864 ..
ANDA 202865 ..
ANDA 203132 ..
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 March 16,
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 16, 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 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03025 Filed 2–13–20; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:56 Feb 13, 2020
Jkt 250001
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Applicant
Do.
Do.
Bausch Health US, LLC, 400 Somerset Corporate Blvd.,
Bridgewater, NJ 08807.
Hikma Pharmaceuticals USA Inc., 1809 Wilson Rd., Columbus, OH 43228.
Hospira, Inc.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Mylan Institutional, LLC, 4901 Hiawatha Dr., Rockford, IL
61103.
Hisun Pharmaceutical Hangzhou Co., LTD, 200 Crossing
Blvd., 2nd Floor, Bridgewater, NJ 08807.
Do.
Food and Drug Administration
by June 15, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
[Docket No. FDA–2018–D–1398]
ADDRESSES:
Mitigation Strategies To Protect Food
Against Intentional Adulteration; Draft
Guidance for Industry; Availability
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing the availability of a
supplemental draft guidance for
industry entitled ‘‘Mitigation Strategies
to Protect Food Against Intentional
Adulteration: Guidance for Industry.’’
This supplemental draft guidance
document, when finalized, will help
food facilities that manufacture, process,
pack, or hold food, and that are required
to register under the Federal Food, Drug,
and Cosmetic Act (FD&C Act) comply
with the requirements of our regulation
entitled ‘‘Mitigation Strategies to Protect
Food Against Intentional Adulteration.’’
DATES: Submit either electronic or
written comments on the draft guidance
SUMMARY:
PO 00000
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You may submit comments
on any guidance at any time as follows:
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
comments, that information will be
posted on https://www.regulations.gov.
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]]>Agencies
[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Notices]
[Pages 8598-8599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03025]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5608]
Wockhardt Limited, et al.; Withdrawal of Approval of 28
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 28 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 16, 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 040732................. Phenytoin Sodium Wockhardt Limited, c/
Capsules, 100 o Morton Grove
milligrams (mg) Pharmaceuticals,
(Extended). Inc., 6451 Main
St., Morton Grove,
IL 60053.
ANDA 065230................. Ceftriaxone for Hospira, Inc., 275
Injection, North Field Dr.,
Equivalent to (EQ) Bldg. H1, Lake
250 mg base/vial; Forest, IL 60045.
EQ 500 mg base/
vial; EQ 1 gram (g)
base/vial; EQ 2 g
base/vial.
ANDA 065231................. Ceftriaxone for Do.
Injection, EQ 1 g
base/vial; EQ 2 g
base/vial Piggy
Back.
ANDA 065290................. Cefotaxime Sodium Do.
for Injection, EQ
500 mg base/vial;
EQ 1 g base/vial;
EQ 2 g base/vial.
ANDA 065292................. Cefotaxime Sodium Do.
for Injection, EQ
10 g base/vial
Pharmacy Bulk
Package.
ANDA 065293................. Cefotaxime Sodium Do.
for Injection, EQ 1
g base/vial; EQ 2 g
base/vial.
ANDA 065312................. Cefoxitin for Do.
Injection, EQ 10 g
base/vial Pharmacy
Bulk Package.
ANDA 065313................. Cefoxitin for Do.
Injection, EQ 1 g
base/vial; EQ 2 g
base/vial.
ANDA 065369................. Cefepime Do.
Hydrochloride (HCl)
for Injection, EQ
500 mg base/vial;
EQ 1 g base/vial;
EQ 2 g base/vial.
ANDA 065483................. Cefuroxime Sodium Do.
for Injection, EQ
750 mg base/vial;
EQ 1.5 g base/vial.
[[Page 8599]]
ANDA 065484................. Cefuroxime Sodium Do.
for Injection, EQ
7.5 g base/vial
Pharmacy Bulk
Package.
ANDA 065503................. Cefuroxime Sodium Do.
for Injection, EQ
1.5 g base/vial.
ANDA 075250................. Prednisolone Sodium Bausch Health US,
Phosphate Oral LLC, 400 Somerset
Solution, EQ 15 mg Corporate Blvd.,
base/5 milliliters Bridgewater, NJ
(mL). 08807.
ANDA 075618................. Acetaminophen, Hikma
Butalbital, Pharmaceuticals USA
Caffeine, and Inc., 1809 Wilson
Codeine Phosphate Rd., Columbus, OH
Capsules, 325 mg, 43228.
50 mg, 40 mg, and
30 mg.
ANDA 090375................. Ampicillin and Hospira, Inc.
Sulbactam for
Injection, EQ 1 g
base/vial and EQ
500 mg base/vial;
EQ 2 g base/vial
and EQ 1 g base/
vial.
ANDA 090646................. Ampicillin and Do.
Sulbactam for
Injection, EQ 10 g
base/vial and EQ 5
g base/vial.
ANDA 090653................. Ampicillin and Do.
Sulbactam for
Injection, EQ 1 g
base/vial and EQ
500 mg base/vial;
EQ 2 g base/vial
and EQ 1 g base/
vial.
ANDA 090825................. Imipenem and Do.
Cilastatin for
Injection, EQ 250
mg base/vial and
250 mg base/vial;
EQ 500 mg base/vial
and 500 mg/vial.
ANDA 090940................. Meropenem for Do.
Injection, 500 mg/
vial, and 1 g/vial.
ANDA 091007................. Imipenem and Do.
Cilastatin for
Injection, EQ 500
mg base/vial and
500 mg/vial.
ANDA 202268................. Cefepime HCl for Do.
Injection, EQ 1 g
base/vial; EQ 2 g
base/vial.
ANDA 202563................. Ceftriaxone for Do.
Injection, EQ 1 g
base/vial; EQ 2 g
base/vial.
ANDA 202864................. Ampicillin Sodium Do.
for Injection, EQ
250 mg base/vial;
EQ 500 mg base/
vial; EQ 1 g base/
vial; EQ 2 g base/
vial.
ANDA 202865................. Ampicillin Sodium Do.
for Injection, EQ
10 g base/vial
Pharmacy Bulk
Package.
ANDA 203132................. Cefotaxime Sodium Do.
for Injection, EQ 1
g base/vial; EQ 2 g
base/vial.
ANDA 204879................. Pyridoxine HCl Mylan Institutional,
Injection, 100 mg/ LLC, 4901 Hiawatha
mL. Dr., Rockford, IL
61103.
ANDA 206062................. Doxorubicin HCl for Hisun Pharmaceutical
Injection, USP, 20 Hangzhou Co., LTD,
mg/vial. 200 Crossing Blvd.,
2nd Floor,
Bridgewater, NJ
08807.
ANDA 206195................. Daunorubicin HCl for Do.
Injection, EQ 20 mg
base/vial.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
16, 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 16, 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 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03025 Filed 2-13-20; 8:45 am]
BILLING CODE 4164-01-P
