Ferndale Laboratories, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications, 19787-19788 [2018-09534]
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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
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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
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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
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19788
Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices
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.
Application No.
Drug
Applicant
ANDA 040259 .........
Hydrocortisone Acetate Cream USP, 2.5% ..........................
ANDA 040457 .........
Pyridostigmine Bromide Tablets USP, 60 milligrams (mg) ...
ANDA 061806 .........
Cloxapen (cloxacillin sodium) Capsules, Equivalent to (EQ)
250 mg base and EQ 500 mg base.
Vancomycin Hydrochloride (HCl) Capsules USP, EQ 125
mg base and EQ 250 mg base.
Calcitriol Injection, 1 microgram (mcg)/milliliter (mL) and 2
mcg/mL.
Rimantadine HCl Tablets USP, 100 mg ................................
Glyburide and Metformin HCl Tablets USP, 1.25 mg/250
mg, 2.5 mg/500 mg, and 5 mg/500 mg.
Fluconazole in Sodium Chloride 0.9% Injection, 200 mg/
100 mL and 400 mg/200 mL.
Ferndale Laboratories, Inc., 780 West Eight Mile Rd., Ferndale, MI 48220.
Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward,
CA 94544.
GlaxoSmithKline, LLC, 5 Crescent Dr., Philadelphia, PA
19112.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
Do.
ANDA 065453 .........
ANDA 075836 .........
ANDA 075916 .........
ANDA 076731 .........
ANDA 076889 .........
ANDA 088572 .........
Impax Laboratories, Inc.
Do.
Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc.,
781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown,
WV 26504.
Abbott Laboratories, One Abbott Park Rd., Abbott Park, IL
60064.
Pediatric LTA Kit (lidocaine HCl) Solution, 2% .....................
Therefore, approval of the
applications listed in the 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)).
Drug products that are listed in the table
that are in inventory on June 4, 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: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Application Due Date has been
modified.
Paul
Gettys, Grant Systems Coordinator, 5600
Fishers Lane, Mail Stop: 09E70,
Rockville, MD 20857, Phone: (301) 443–
2114; or the Division of Grants
Management main line (301) 443–5204,
or Fax: (301)–594–0899.
FOR FURTHER INFORMATION CONTACT:
Correction
In the FR notice of April 17, 2018, (FR
2018–07941), the correction is:
Key Dates:
Under the heading Key Dates, the
Application Due Date should read as:
• Application Due Date: June 18,
2018
The other dates in the Key Dates
section remain as originally published.
Dated: April 27, 2018.
Michael D. Weahkee,
RADM, Assistant Surgeon General, U.S.
Public Health Service, Acting Director, Indian
Health Service.
[FR Doc. 2018–09534 Filed 5–3–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–09506 Filed 5–3–18; 8:45 am]
BILLING CODE 4160–16–P
Indian Health Service
amozie on DSK3GDR082PROD with NOTICES
ACTION:
Dated: April 27, 2018.
Michael D. Weahkee,
Assistant Surgeon General, U.S. Public Health
Service, Acting Director, Indian Health
Service.
The Indian Health Service
published a notice in the Federal
Register (FR) on April 17, 2018, for the
Negotiation Cooperative Agreement,
Funding Announcement Number: HHS–
2018–IHS–TSGN–0001. The
SUMMARY:
Jkt 244001
BILLING CODE 4165–16–P
Indian Health Service
Notice; Correction of due date.
18:16 May 03, 2018
In the FR notice of April 17, 2018, (FR
83 FR 16885), the correction is:
Key Dates:
Under the heading Key Dates, the
Application Due Date should read as:
• Application Due Date: June 18, 2018
The other dates in the Key Dates
section remain as originally published.
[FR Doc. 2018–09507 Filed 5–3–18; 8:45 am]
Indian Health Service, HHS.
VerDate Sep<11>2014
Correction
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Tribal Self-Governance;
Negotiation Cooperative Agreement;
Correction of Due Date
AGENCY:
Register on April 17, 2018, for the
Planning Cooperative Agreement,
Funding Announcement Number: HHS–
2018–IHS–TSGP–0001. The Application
Due Date has been modified.
FOR FURTHER INFORMATION CONTACT: Paul
Gettys, Grant Systems Coordinator, 5600
Fishers Lane, Mail Stop: 09E70,
Rockville, MD 20857, Phone: (301) 443–
2114; or the Division of Grants
Management main line (301) 443–5204,
or Fax: (301) 594–0899.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Planning Cooperative Agreement;
Correction of Due Date
National Institutes of Health
Office of Tribal SelfGovernance, Indian Health Service,
HHS.
ACTION: Notice; correction of due date.
AGENCY:
The Indian Health Service
published a notice in the Federal
SUMMARY:
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National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
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]]>Agencies
[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Notices]
[Pages 19787-19788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09534]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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: 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 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,
[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
[[Page 19788]]
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 040259..................... Hydrocortisone Ferndale
Acetate Cream Laboratories,
USP, 2.5%. Inc., 780 West
Eight Mile Rd.,
Ferndale, MI
48220.
ANDA 040457..................... Pyridostigmine Impax
Bromide Tablets Laboratories,
USP, 60 Inc., 30831
milligrams (mg). Huntwood Ave.,
Hayward, CA
94544.
ANDA 061806..................... Cloxapen GlaxoSmithKline,
(cloxacillin LLC, 5 Crescent
sodium) Capsules, Dr.,
Equivalent to Philadelphia, PA
(EQ) 250 mg base 19112.
and EQ 500 mg
base.
ANDA 065453..................... Vancomycin Fresenius Kabi
Hydrochloride USA, LLC, Three
(HCl) Capsules Corporate Dr.,
USP, EQ 125 mg Lake Zurich, IL
base and EQ 250 60047.
mg base.
ANDA 075836..................... Calcitriol Do.
Injection, 1
microgram (mcg)/
milliliter (mL)
and 2 mcg/mL.
ANDA 075916..................... Rimantadine HCl Impax
Tablets USP, 100 Laboratories,
mg. Inc.
ANDA 076731..................... Glyburide and Do.
Metformin HCl
Tablets USP, 1.25
mg/250 mg, 2.5 mg/
500 mg, and 5 mg/
500 mg.
ANDA 076889..................... Fluconazole in Mylan
Sodium Chloride Laboratories,
0.9% Injection, Ltd., c/o Mylan
200 mg/100 mL and Pharmaceuticals,
400 mg/200 mL. Inc., 781
Chestnut Ridge
Rd., P.O. Box
4310, Morgantown,
WV 26504.
ANDA 088572..................... Pediatric LTA Kit Abbott
(lidocaine HCl) Laboratories, One
Solution, 2%. Abbott Park Rd.,
Abbott Park, IL
60064.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the 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)). Drug products that are listed in the table that
are in inventory on June 4, 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: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09534 Filed 5-3-18; 8:45 am]
BILLING CODE 4164-01-P
