Aurolife Pharma, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications, 16269-16270 [2019-07833]
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Federal Register / Vol. 84, No. 75 / Thursday, April 18, 2019 / Notices
B. Purpose
Firms performing under Federal
contracts must provide adequate
documentation to support requests for
payment under these contracts. The
documentation may range from a simple
invoice to detailed cost data. The
information is usually submitted once,
at the end of the contract period or upon
delivery of the supplies or services, but
could be submitted more often
depending on the payment schedule
established under the contract (see
Federal Acquisition Regulation (FAR)
52.232–1 through FAR 52.232–4, FAR
52.232–6, 52.232–7, and 52.232–10).
jbell on DSK30RV082PROD with NOTICES
C. Annual Reporting Burden
Respondents: 1,724,163.
Responses per Respondent: 6.
Annual Responses: 10,344,978.
Hours per Response: 0.25.
Total Burden Hours: 2,586,245.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW, Washington, DC
20405, at 202–501–4755. Please cite
OMB Control No. 9000–0070, Payments,
in all correspondence.
Dated: April 15, 2019.
Janet Fry,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2019–07816 Filed 4–17–19; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1020]
Aurolife Pharma, LLC, et al.;
Withdrawal of Approval of 31
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 31 abbreviated
new drug applications (ANDAs) from
SUMMARY:
16269
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applications be withdrawn.
Approval is withdrawn as of
May 20, 2019.
DATES:
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945,
Trang.Tran@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 their
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 070470 ...............
ANDA 070471 ...............
ANDA 070531 ...............
Disopyramide Phosphate Capsules USP, Equivalent to (EQ) 100 milligrams (mg) base.
Disopyramide Phosphate Capsules USP, EQ 150 mg base ................
Clofibrate Capsules USP, 500 mg ........................................................
ANDA 070797 ...............
ANDA 070956 ...............
Chlorpheniramine Maleate Extended-Release Capsules USP, 12 mg
Diazepam Tablets USP, 10 mg ............................................................
ANDA 071128 ...............
Haloperidol Tablets USP, 0.5 mg .........................................................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
...............
...............
...............
...............
...............
...............
...............
...............
...............
Haloperidol Tablets USP, 1 mg ............................................................
Haloperidol Tablets USP, 20 mg ..........................................................
Fenoprofen Calcium Capsules USP, EQ 200 mg base .......................
Fenoprofen Calcium Capsules USP, EQ 300 mg base .......................
Fenoprofen Calcium Tablets USP, EQ 600 mg base ...........................
Trazodone Hydrochloride (HCl) Tablets USP, 50 mg ..........................
Ketoprofen Capsules, 50 mg and 75 mg ..............................................
Flurbiprofen Tablets USP, 50 mg and 100 mg .....................................
Pamidronate Disodium for Injection USP, 30 mg/vial and 90 mg/vial ..
ANDA 080655 ...............
ANDA 083234 ...............
Meprobamate Tablets USP, 400 mg ....................................................
Glutethimide Tablets, 500 mg ...............................................................
ANDA 084156 ...............
Pentobarbital Sodium Capsules, 100 mg .............................................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
Aminophylline Tables USP, 100 mg .....................................................
Sulfisoxazole Tablets USP, 500 mg .....................................................
Prednisone Tablets USP, 20 mg ..........................................................
Sulfamethoxazole Tablets USP, 500 mg ..............................................
Amitriptyline HCl Tablets USP, 50 mg ..................................................
Amitriptyline HCl Tablets USP, 75 mg ..................................................
Amitriptyline HCl Tablets USP, 100 mg ................................................
Cyproheptadine HCl Tablets USP, 4 mg ..............................................
Hydroxyzine HCl Tablets USP, 25 mg ..................................................
Quinidine Gluconate Extended-Release Tablets USP, 324 mg ...........
Prednisone Tablets USP, 10 mg ..........................................................
Aurolife Pharma, LLC, 279 Princeton
Hightstown Rd., East Windsor, NJ 08520.
Do.
Upsher-Smith Laboratories, LLC, 301 South
Cherokee St., Denver, CO 80223.
Aurolife Pharma, LLC.
Halsey Drug Co., Inc., 1827 Pacific St.,
Brooklyn, NY 11233.
Cycle Pharmaceuticals, Ltd., c/o Mapi USA,
Inc., 2343 Alexandria Dr., Suite 100, Lexington, KY 40504.
Do.
Do.
Aurolife Pharma, LLC.
Do.
Do.
Do.
Do.
Do.
Mustafa Nevzat Ilac San. A.S. (MN Pharmaceuticals), c/o Sagent Pharmaceuticals,
Inc., 1901 North Roselle Rd., suite 450,
Schaumburg, IL 60195.
Aurolife Pharma, LLC.
Upsher-Smith
Laboratories,
LLC,
6701
Evenstad Dr. North, Maple Grove, MN
55369.
Warner-Lambert Company, 201 Tabor Rd.,
Morris Plains, NJ 07950.
Halsey Drug Co., Inc.
Aurolife Pharma, LLC.
Do.
Do.
Halsey Drug Co., Inc.
Do.
Do.
Do.
Do.
Aurolife Pharma, LLC.
Do.
071129
071133
072394
072395
072396
072484
074024
074448
078300
084674
085628
085813
085844
085925
085926
085927
089057
089117
089894
089983
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18APN1
16270
Federal Register / Vol. 84, No. 75 / Thursday, April 18, 2019 / Notices
Application No.
Drug
Applicant
ANDA 089984 ...............
ANDA 208991 ...............
Prednisone Tablets USP, 50 mg ..........................................................
Piroxicam Capsules USP, 10 mg and 20 mg .......................................
Do.
Breckenridge
Pharmaceutical,
Inc.,
15
Massirio Dr., suite 201, Berlin, CT 06037.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of May 20, 2019.
Approval of each entire application is
withdrawn, including any strengths or
products 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 May 20, 2019
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: April 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–07833 Filed 4–17–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1517]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Abbreviated New
Animal Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of abbreviated new
animal drug applications.
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SUMMARY:
VerDate Sep<11>2014
17:37 Apr 17, 2019
Jkt 247001
Submit either electronic or
written comments on the collection of
information by June 17, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 17, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 17, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
DATES:
Electronic Submissions
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.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
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well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–1517 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Abbreviated New Animal Drug
Applications. ’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
E:\FR\FM\18APN1.SGM
18APN1
]]>Agencies
[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Notices]
[Pages 16269-16270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07833]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1020]
Aurolife Pharma, LLC, et al.; Withdrawal of Approval of 31
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 31 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 May 20, 2019.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
[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 070470........................... Disopyramide Phosphate Capsules USP, Aurolife Pharma, LLC, 279
Equivalent to (EQ) 100 milligrams (mg) Princeton Hightstown Rd.,
base. East Windsor, NJ 08520.
ANDA 070471........................... Disopyramide Phosphate Capsules USP, EQ Do.
150 mg base.
ANDA 070531........................... Clofibrate Capsules USP, 500 mg......... Upsher-Smith Laboratories,
LLC, 301 South Cherokee St.,
Denver, CO 80223.
ANDA 070797........................... Chlorpheniramine Maleate Extended- Aurolife Pharma, LLC.
Release Capsules USP, 12 mg.
ANDA 070956........................... Diazepam Tablets USP, 10 mg............. Halsey Drug Co., Inc., 1827
Pacific St., Brooklyn, NY
11233.
ANDA 071128........................... Haloperidol Tablets USP, 0.5 mg......... Cycle Pharmaceuticals, Ltd., c/
o Mapi USA, Inc., 2343
Alexandria Dr., Suite 100,
Lexington, KY 40504.
ANDA 071129........................... Haloperidol Tablets USP, 1 mg........... Do.
ANDA 071133........................... Haloperidol Tablets USP, 20 mg.......... Do.
ANDA 072394........................... Fenoprofen Calcium Capsules USP, EQ 200 Aurolife Pharma, LLC.
mg base.
ANDA 072395........................... Fenoprofen Calcium Capsules USP, EQ 300 Do.
mg base.
ANDA 072396........................... Fenoprofen Calcium Tablets USP, EQ 600 Do.
mg base.
ANDA 072484........................... Trazodone Hydrochloride (HCl) Tablets Do.
USP, 50 mg.
ANDA 074024........................... Ketoprofen Capsules, 50 mg and 75 mg.... Do.
ANDA 074448........................... Flurbiprofen Tablets USP, 50 mg and 100 Do.
mg.
ANDA 078300........................... Pamidronate Disodium for Injection USP, Mustafa Nevzat Ilac San. A.S.
30 mg/vial and 90 mg/vial. (MN Pharmaceuticals), c/o
Sagent Pharmaceuticals, Inc.,
1901 North Roselle Rd., suite
450, Schaumburg, IL 60195.
ANDA 080655........................... Meprobamate Tablets USP, 400 mg......... Aurolife Pharma, LLC.
ANDA 083234........................... Glutethimide Tablets, 500 mg............ Upsher-Smith Laboratories,
LLC, 6701 Evenstad Dr. North,
Maple Grove, MN 55369.
ANDA 084156........................... Pentobarbital Sodium Capsules, 100 mg... Warner-Lambert Company, 201
Tabor Rd., Morris Plains, NJ
07950.
ANDA 084674........................... Aminophylline Tables USP, 100 mg........ Halsey Drug Co., Inc.
ANDA 085628........................... Sulfisoxazole Tablets USP, 500 mg....... Aurolife Pharma, LLC.
ANDA 085813........................... Prednisone Tablets USP, 20 mg........... Do.
ANDA 085844........................... Sulfamethoxazole Tablets USP, 500 mg.... Do.
ANDA 085925........................... Amitriptyline HCl Tablets USP, 50 mg.... Halsey Drug Co., Inc.
ANDA 085926........................... Amitriptyline HCl Tablets USP, 75 mg.... Do.
ANDA 085927........................... Amitriptyline HCl Tablets USP, 100 mg... Do.
ANDA 089057........................... Cyproheptadine HCl Tablets USP, 4 mg.... Do.
ANDA 089117........................... Hydroxyzine HCl Tablets USP, 25 mg...... Do.
ANDA 089894........................... Quinidine Gluconate Extended-Release Aurolife Pharma, LLC.
Tablets USP, 324 mg.
ANDA 089983........................... Prednisone Tablets USP, 10 mg........... Do.
[[Page 16270]]
ANDA 089984........................... Prednisone Tablets USP, 50 mg........... Do.
ANDA 208991........................... Piroxicam Capsules USP, 10 mg and 20 mg. Breckenridge Pharmaceutical,
Inc., 15 Massirio Dr., suite
201, Berlin, CT 06037.
----------------------------------------------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of May
20, 2019. Approval of each entire application is withdrawn, including
any strengths or products 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 May 20,
2019 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: April 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07833 Filed 4-17-19; 8:45 am]
BILLING CODE 4164-01-P
