Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications, 64131-64132 [2018-26947]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices
amozie on DSK3GDR082PROD with NOTICES1
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
IC–GREEN (indocyanine green for
injection), 10 mg/vial, 25 mg/vial, 40
mg/vial, and 50 mg/vial, is the subject
of NDA 011525, held by Akorn, Inc. IC–
GREEN (indocyanine green for
injection), 25 mg/vial and 50 mg/vial,
became conditionally effective on
February 2, 1959. IC–GREEN
(indocyanine green for injection), 10
mg/vial and 40 mg/vial, became
conditionally effective on March 20,
1967. NDA 011525 was included in the
Drug Efficacy Study Implementation
review, (35 FR 12231 (July 30, 1970); 42
FR 31495 (June 21, 1977)) and the
application was approved on August 2,
1989. IC–GREEN (indocyanine green for
injection) is indicated for determining
cardiac output, hepatic function, and
liver blood flow, and for ophthalmic
angiography.
IC–GREEN (indocyanine green for
injection), 10 mg/vial, 40 mg/vial, and
50 mg/vial, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Foley & Lardner LLP submitted a
citizen petition dated May 3, 2018
(Docket No. FDA–2018–P–1734), under
21 CFR 10.30, requesting that the
Agency determine whether IC–GREEN
(indocyanine green for injection), 10
mg/vial, 40 mg/vial, and 50 mg/vial,
was withdrawn from sale for reasons of
safety or effectiveness. In 1987, IC–
GREEN (indocyanine green for
injection), 10 mg/vial and 40 mg/vial
were discontinued from marketing. In
1996, Akorn, Inc. discontinued
marketing IC–GREEN (indocyanine
green for injection), 50mg/vial.
After considering the citizen petition
and reviewing Agency records, and
based on the information we have at this
time, FDA has determined under
§ 314.161 that IC–GREEN (indocyanine
green for injection), 10 mg/vial, 40 mg/
vial, and 50 mg/vial, was not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that IC–
GREEN (indocyanine green for
injection), 10 mg/vial, 40 mg/vial, and
50 mg/vial, was withdrawn for reasons
of safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of IC–
GREEN (indocyanine green for
injection), 10 mg/vial, 40 mg/vial, and
50 mg/vial from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that these drug products
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list IC–GREEN (indocyanine
green for injection), 10 mg/vial, 40 mg/
vial, and 50 mg/vial, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to IC–GREEN (indocyanine green for
injection), 10 mg/vial, 40 mg/vial, and
50 mg/vial, may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: December 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26975 Filed 12–12–18; 8:45 am]
BILLING CODE 4164–01–P
64131
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4416]
Allied Pharma, Inc., et al.; Withdrawal
of Approval of Nine Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of nine
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
January 14, 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 073079 .................................
ANDA 076741 .................................
Loperamide Hydrochloride (HCl) Oral Solution, 1
milligram (mg)/5 milliliters.
Ibuprofen Tablets USP, 100 mg ................................
ANDA 080210 .................................
Lidocaine Ointment, 5% ............................................
ANDA 085497 .................................
Phendimetrazine Tartrate Tablets, 35 mg .................
ANDA 085695 .................................
ANDA 086365 .................................
ANDA 086399 .................................
Phendimetrazine Tartrate Capsules, 35 mg .............
Phendimetrazine Tartrate Tablets, 35 mg .................
Theolair (theophylline) Tablets, 125 mg and 250 mg
ANDA 087378 .................................
Phendimetrazine Tartrate Extended-Release Capsules, 105 mg.
Bromfenac Sodium Ophthalmic Solution, Equivalent
to 0.09% Acid.
Allied Pharma, Inc., 20 Corrielle St., Fords, NJ
08863.
LNK International, Inc., 145 Ricefield Ln.,
Hauppauge, NY 11788.
Belmora, LLC, 2231 Crystal Dr., #1000, Arlington,
VA 22202.
Virtus Pharmaceuticals, LLC, 2050 Cabot Blvd.
West, 2nd Floor, Langhorne, PA 19047.
Do.
Do.
Medicis Pharmaceutical Corp., c/o Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
Virtus Pharmaceuticals, LLC.
ANDA 202030 .................................
VerDate Sep<11>2014
17:12 Dec 12, 2018
Jkt 247001
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Amring Pharmaceuticals, Inc., 1235 Westlakes Dr.,
Suite 205, Berwyn, PA 19312.
E:\FR\FM\13DEN1.SGM
13DEN1
64132
Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 14,
2019. 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 January 14,
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: December 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26947 Filed 12–12–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3984]
Data Integrity and Compliance With
Drug CGMP: Questions and Answers;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Data
Integrity and Compliance With Drug
CGMP: Questions and Answers.’’ The
purpose of the guidance is to clarify the
role of data integrity in current good
manufacturing practice (CGMP) for
drugs. (Unless otherwise noted, the term
CGMP refers to CGMPs for drugs,
including biologics.) The guidance has
been developed in response to an
increase in findings of data integrity
lapses in recent inspections. FDA
expects that all data be reliable and
accurate. CGMP regulations and
guidance allow for flexible and riskbased strategies to prevent and detect
data integrity issues. Firms should
implement meaningful and effective
strategies to manage their data integrity
risks based on their process
understanding and knowledge
management of technologies and
business models.
DATES: The announcement of the
guidance is published in the Federal
Register on December 13, 2018.
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:12 Dec 12, 2018
Jkt 247001
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
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
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–
2018–D–3984 for ‘‘Data Integrity and
Compliance With Drug CGMP:
Questions and Answers.’’ Received
comments 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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002; or
the Policy and Regulations Staff (HFV–
6), Center for Veterinary Medicine, Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Notices]
[Pages 64131-64132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26947]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4416]
Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine
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 nine 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 14, 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 073079..................... Loperamide Allied Pharma,
Hydrochloride Inc., 20
(HCl) Oral Corrielle St.,
Solution, 1 Fords, NJ 08863.
milligram (mg)/5
milliliters.
ANDA 076741..................... Ibuprofen Tablets LNK International,
USP, 100 mg. Inc., 145
Ricefield Ln.,
Hauppauge, NY
11788.
ANDA 080210..................... Lidocaine Belmora, LLC, 2231
Ointment, 5%. Crystal Dr.,
#1000, Arlington,
VA 22202.
ANDA 085497..................... Phendimetrazine Virtus
Tartrate Tablets, Pharmaceuticals,
35 mg. LLC, 2050 Cabot
Blvd. West, 2nd
Floor, Langhorne,
PA 19047.
ANDA 085695..................... Phendimetrazine Do.
Tartrate
Capsules, 35 mg.
ANDA 086365..................... Phendimetrazine Do.
Tartrate Tablets,
35 mg.
ANDA 086399..................... Theolair Medicis
(theophylline) Pharmaceutical
Tablets, 125 mg Corp., c/o
and 250 mg. Valeant
Pharmaceuticals
North America,
LLC, 400 Somerset
Corporate Blvd.,
Bridgewater, NJ
08807.
ANDA 087378..................... Phendimetrazine Virtus
Tartrate Extended- Pharmaceuticals,
Release Capsules, LLC.
105 mg.
ANDA 202030..................... Bromfenac Sodium Amring
Ophthalmic Pharmaceuticals,
Solution, Inc., 1235
Equivalent to Westlakes Dr.,
0.09% Acid. Suite 205,
Berwyn, PA 19312.
------------------------------------------------------------------------
[[Page 64132]]
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 14, 2019. 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 January 14, 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: December 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26947 Filed 12-12-18; 8:45 am]
BILLING CODE 4164-01-P
