Sun Pharmaceutical Industries, Ltd.; Withdrawal of Approval of Three Abbreviated New Drug Applications, 19787 [2018-09533]
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Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices
Dated: April 23, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
incorrect docket number. This
document corrects that error.
Lisa
Granger, Office of Policy and Planning,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
3330, Silver Spring, MD 20993–0002,
301–796–9115.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Tuesday, April 9,
2018 (83 FR 15152), in FR Doc. 2018–
07147, on page 15152, the following
correction is made:
1. On page 15152, in the second
column, in the first line of the list of
docket numbers, ‘‘FDA–2014–N–0075’’
is corrected to read ‘‘FDA–2011–N–
0075.’’
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2011–N–0075; FDA–
2011–N–0015; FDA–2011–N–0076; FDA–
2017–N–0932; FDA–2016–N–4487; FDA–
2014–N–0345; FDA–2013–N–0523; FDA–
2017–N–2428; FDA–2008–N–0312; and
FDA–2014–N–1072]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals;
Correction
AGENCY:
Food and Drug Administration,
Dated: April 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–09437 Filed 5–3–18; 8:45 am]
BILLING CODE 4164–01–P
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals’’
that appeared in the Federal Register of
April 9, 2018. The document announced
a list of information collections that
have been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
The document was published with an
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1534]
Sun Pharmaceutical Industries, Ltd.;
Withdrawal of Approval of Three
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of three
abbreviated new drug applications
(ANDAs) held by Sun Pharmaceutical
Industries, Ltd., c/o Sun Pharmaceutical
Industries, Inc. (Sun Pharmaceutical).
These drug products are no longer
marketed, and Sun Pharmaceutical has
requested that the approval of the
applications be withdrawn.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–09532 Filed 5–3–18; 8:45 am]
19787
Notice.
Approval is withdrawn as of
June 4, 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,
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
Sun
Pharmaceutical has informed FDA that
these drug products are no longer
marketed and requested that FDA
withdraw approval of the applications.
Sun Pharmaceutical has also waived its
opportunity for a hearing and requested
withdrawal of approval under a Consent
Decree of Permanent Injunction (Decree)
entered in United States v. Ranbaxy
Laboratories, Ltd. et al., JFM 12–250 (D.
Md.) on January 26, 2012. The Decree
specifies that Sun Pharmaceutical must
never submit another application to
FDA for these withdrawn drugs and
must never transfer these ANDAs to a
third party.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 065174 .........
Clarithromycin Tablets USP, 250 milligrams (mg) and 500
mg.
ANDA 065382 .........
Clarithromycin for Oral Suspension USP, 125 mg/5 milliliters (mL) and 250 mg/5 mL.
Ciprofloxacin Tablets USP, Equivalent to (EQ) 250 mg
base, EQ 500 mg base, and EQ 750 mg base.
Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton,
NJ 08540.
Do.
ANDA 075747 .........
Do.
amozie on DSK3GDR082PROD with NOTICES
Therefore, approval of the
applications listed in the above table,
and all amendments and supplements
thereto, is hereby withdrawn as of June
4, 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)).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
HHS.
[FR Doc. 2018–09533 Filed 5–3–18; 8:45 am]
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VerDate Sep<11>2014
18:16 May 03, 2018
Jkt 244001
Food and Drug Administration
[Docket No. FDA–2018–N–1564]
Ferndale Laboratories, Inc., et al.;
Withdrawal of Approval of Nine
Abbreviated New Drug Applications
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of nine
abbreviated new drug applications
(ANDAs) from multiple applicants. The
SUMMARY:
PO 00000
Frm 00108
Fmt 4703
Sfmt 4703
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
June 4, 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,
Trang.Tran@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
holders of the applications listed in the
table have informed FDA that these drug
products are no longer marketed and
E:\FR\FM\04MYN1.SGM
04MYN1
]]>Agencies
[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Notices]
[Page 19787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09533]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1534]
Sun Pharmaceutical Industries, Ltd.; Withdrawal of Approval of
Three 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 three abbreviated new drug applications (ANDAs)
held by Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical
Industries, Inc. (Sun Pharmaceutical). These drug products are no
longer marketed, and Sun Pharmaceutical has requested that the approval
of the applications be withdrawn.
DATES: Approval is withdrawn as of June 4, 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: Sun Pharmaceutical has informed FDA that
these drug products are no longer marketed and requested that FDA
withdraw approval of the applications. Sun Pharmaceutical has also
waived its opportunity for a hearing and requested withdrawal of
approval under a Consent Decree of Permanent Injunction (Decree)
entered in United States v. Ranbaxy Laboratories, Ltd. et al., JFM 12-
250 (D. Md.) on January 26, 2012. The Decree specifies that Sun
Pharmaceutical must never submit another application to FDA for these
withdrawn drugs and must never transfer these ANDAs to a third party.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 065174..................... Clarithromycin Sun Pharmaceutical
Tablets USP, 250 Industries, Ltd.,
milligrams (mg) c/o Sun
and 500 mg. Pharmaceutical
Industries, Inc.,
2 Independence
Way, Princeton,
NJ 08540.
ANDA 065382..................... Clarithromycin for Do.
Oral Suspension
USP, 125 mg/5
milliliters (mL)
and 250 mg/5 mL.
ANDA 075747..................... Ciprofloxacin Do.
Tablets USP,
Equivalent to
(EQ) 250 mg base,
EQ 500 mg base,
and EQ 750 mg
base.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the above table,
and all amendments and supplements thereto, is hereby withdrawn as of
June 4, 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)).
Dated: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09533 Filed 5-3-18; 8:45 am]
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