Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications, 27128 [2019-12287]
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27128
Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices
Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Notice.
Food and Drug Administration
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applications be withdrawn.
[Docket No. FDA–2019–N–1740]
DATES:
[FR Doc. 2019–12298 Filed 6–10–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Novartis Pharmaceuticals Corp., et al.;
Withdrawal of Approval of Six
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Application No.
SUMMARY:
Approval is withdrawn as of July
11, 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,
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:
Applicant
ANDA 070185 .........
Fluor-Op (fluorometholone) Ophthalmic Suspension, 0.1%
ANDA 070858 .........
Trazodone Hydrochloride Tablets USP, 100 milligrams (mg)
ANDA 076023 .........
ANDA 078167 .........
ANDA 088726 .........
Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200
mg.
Paclitaxel Injection USP, 6 mg/milliliter .................................
Chlorpropamide Tablets USP, 250 mg .................................
ANDA 089852 .........
Chlorzoxazone Tablets USP, 250 mg ...................................
Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12287 Filed 6–10–19; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
Drug
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of July 11, 2019.
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 July 11, 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.
khammond on DSKBBV9HB2PROD with NOTICES
ACTION:
17:36 Jun 10, 2019
Jkt 247001
Novartis Pharmaceuticals Corp., One Health Plaza, East
Hanover, NJ 07936.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy.,
Bldg. A, Parsippany, NJ 07054.
Sandoz, Inc., 100 College Rd. West, Princeton, NJ 08540.
Aurolife Pharma, LLC, 279 Princeton Hightstown Rd., East
Windsor, NJ 08520.
Do.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–E–0068; FDA–
2018–E–0069; FDA–2018–E–0070; FDA–
2018–E–0071; and FDA–2018–E–0072]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; KISQALI
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for KISQALI and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of
patents which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 12, 2019.
Furthermore, any interested person may
SUMMARY:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 9, 2019. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
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 August 12,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 12, 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.
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
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Page 27128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12287]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1740]
Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of
Six 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 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 July 11, 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 070185............... Fluor-Op Novartis
(fluorometholone) Pharmaceuticals
Ophthalmic Corp., One Health
Suspension, 0.1%. Plaza, East Hanover,
NJ 07936.
ANDA 070858............... Trazodone Watson Laboratories,
Hydrochloride Inc., Subsidiary of
Tablets USP, 100 Teva Pharmaceuticals
milligrams (mg). USA, Inc., 425
Privet Rd., Horsham,
PA 19044.
ANDA 076023............... Hydrocodone Teva Pharmaceuticals
Bitartrate and USA, Inc., 400
Ibuprofen Tablets, Interpace Pkwy.,
7.5 mg/200 mg. Bldg. A, Parsippany,
NJ 07054.
ANDA 078167............... Paclitaxel Injection Sandoz, Inc., 100
USP, 6 mg/milliliter. College Rd. West,
Princeton, NJ 08540.
ANDA 088726............... Chlorpropamide Aurolife Pharma, LLC,
Tablets USP, 250 mg. 279 Princeton
Hightstown Rd., East
Windsor, NJ 08520.
ANDA 089852............... Chlorzoxazone Tablets Do.
USP, 250 mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of July
11, 2019. 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 July 11, 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: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12287 Filed 6-10-19; 8:45 am]
BILLING CODE 4164-01-P
