Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four Abbreviated New Drug Applications, 11208 [2018-05120]
Download as PDF
<![CDATA[
11208
Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices
approval of four abbreviated new drug
applications (ANDAs) from two
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0793]
Sun Pharmaceutical Industries, Ltd.,
and Sun Pharma Global FZE;
Withdrawal of Approval of Four
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Approval is withdrawn as of
April 13, 2018.
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,
Notice.
The Food and Drug
Administration (FDA) is withdrawing
SUMMARY:
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
The
holders of the applications 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 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 075556 ........
Enalapril Maleate Tablets USP, 2.5 milligrams (mg), 5 mg,
10 mg, and 20 mg.
ANDA 076045 ........
ANDA 078055 ........
ANDA 090018 ........
Lorazepam Tablets USP, 0.5 mg, 1 mg, and 2 mg ..............
Zolpidem Tartrate Tablets USP, 5 mg and 10 mg ................
Zoledronic Acid for Injection, Equivalent to 4 mg base/vial ..
Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton,
NJ 08540.
Do.
Do.
Sun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of April 13,
2018. 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 April 13, 2018
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: March 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05120 Filed 3–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
daltland on DSKBBV9HB2PROD with NOTICES
[Docket No. FDA–2018–N–0987]
Patient-Focused Drug Development on
Opioid Use Disorder; Public Meeting;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
SUMMARY:
VerDate Sep<11>2014
18:17 Mar 13, 2018
Jkt 244001
we) is announcing the following public
meeting entitled ‘‘Patient-Focused Drug
Development on Opioid Use Disorder.’’
The purpose of the public meeting is to
obtain patients’ perspectives on the
impacts of and treatment approaches for
opioid use disorder (OUD). This
meeting is a part of FDA’s ongoing work
aimed at reducing the impact of opioid
abuse and addiction.
DATES: The public meeting will be held
on April 17, 2018, from 10 a.m. to 4
p.m. Submit either electronic or written
comments on this public meeting by
June 18, 2018. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public meeting will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/Workingat
FDA/BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
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 18, 2018. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
June 18, 2018. Comments received by
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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
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:
E:\FR\FM\14MRN1.SGM
14MRN1
]]>Agencies
[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Page 11208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05120]
[[Page 11208]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0793]
Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE;
Withdrawal of Approval of Four Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of four abbreviated new drug applications (ANDAs) from two applicants.
The holders of the applications 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 April 13, 2018.
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 holders of the applications 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 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 075556.................. Enalapril Maleate Sun Pharmaceutical
Tablets USP, 2.5 Industries, Ltd.,
milligrams (mg), 5 c/o Sun
mg, 10 mg, and 20 Pharmaceutical
mg. Industries, Inc.,
2 Independence
Way, Princeton, NJ
08540.
ANDA 076045.................. Lorazepam Tablets Do.
USP, 0.5 mg, 1 mg,
and 2 mg.
ANDA 078055.................. Zolpidem Tartrate Do.
Tablets USP, 5 mg
and 10 mg.
ANDA 090018.................. Zoledronic Acid for Sun Pharma Global
Injection, FZE, c/o Sun
Equivalent to 4 mg Pharmaceutical
base/vial. Industries, Inc.,
2 Independence
Way, Princeton, NJ
08540.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of April
13, 2018. 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 April 13, 2018 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: March 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05120 Filed 3-13-18; 8:45 am]
BILLING CODE 4164-01-P
