Oxford Pharmaceuticals, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications, 15577-15578 [2018-07440]
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Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
associations and public advocacy
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Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20850.
Dated: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07416 Filed 4–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ACTION:
15577
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 18 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withdrawn.
SUMMARY:
Approval is withdrawn as of
May 11, 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.
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:
[Docket No. FDA–2018–N–1336]
Oxford Pharmaceuticals, LLC, et al.;
Withdrawal of Approval of 18
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Application No.
Drug
Applicant
ANDA 040252 ........
Carisoprodol and Aspirin Tablets USP, 200 milligrams (mg)/
325 mg.
Carisoprodol, Aspirin, and Codeine Phosphate Tablets USP,
200 mg/325 mg/16 mg.
Tetracycline Hydrochloride (HCl) Capsules USP, 250 mg
and 500 mg.
Tetracycline HCl Tablets, 500 mg ..........................................
Oxford Pharmaceuticals, LLC, 301 Leaf Lake Pkwy., Birmingham, AL 35211.
Do.
ANDA 040283 ........
ANDA 061214 ........
ANDA 061682 ........
ANDA 062212 ........
ANDA 062654 ........
amozie on DSK30RV082PROD with NOTICES
ANDA 062680 ........
Totacillin (ampicillin/ampicillin trihydrate) Capsules, Equivalent to (EQ) 250 mg base and EQ 500 mg base.
Rocephin (ceftriaxone sodium) for Injection, EQ 500 mg
base/vial, EQ 1 gram (g) base/vial, and EQ 2 g base/vial.
Oxacillin Sodium for Injection (Pharmacy Bulk Package) .....
ANDA 065124 ........
Cefotaxime for Injection USP, EQ 500 mg base/vial, EQ 1 g
base/vial, and EQ 2 g base/vial.
ANDA 065263 ........
Ceftriaxone for Injection USP, EQ 10 g base/vial (Pharmacy
Bulk Package).
Diltiazem HCl Extended-Release Capsules USP, 60 mg, 90
mg, and 120 mg.
ANDA 074845 ........
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17:17 Apr 10, 2018
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Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH
43228.
Mylan Pharmaceuticals Inc., P.O. Box 4293, Morgantown,
WV 26505.
GlaxoSmithKline, Five Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709.
Hoffman La-Roche, Inc., c/o Genentech, Inc., 1 DNA Way,
MS 241B, South San Francisco, CA 94080.
ACS Dobfar S.p.A., c/o Interchem Corp., 120 Route 17
North, Paramus, NJ 07653.
Lupin Ltd., c/o Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 24th Floor, Baltimore, MD
21202.
Do.
Biovail Corp. International, Subsidiary of Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate
Blvd., Bridgewater, NJ 08807.
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11APN1
15578
Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
Application No.
Drug
Applicant
ANDA 077173 ........
Ondansetron Injection USP, EQ 2 mg base/milliliter (mL) ....
ANDA 078598 ........
Ciprofloxacin Ophthalmic Solution USP, EQ 0.3% base .......
ANDA 078805 ........
Irinotecan HCl Injection, 20 mg/mL ........................................
ANDA 086024 ........
Capital and Codeine (acetaminophen and codeine phosphate) Oral Suspension USP, 120 mg/12 mg per 5 mL.
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution,
EQ 2% base/EQ 0.5% base.
Sun Pharmaceutical Industries Ltd., c/o Sun Pharmaceutical
Industries, Inc., 2 Independence Way, Princeton, NJ
08540.
Amring Pharmaceuticals, Inc., 1235 Westlakes Dr., Suite
205, Berwyn, PA 19312.
Sun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540.
Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
Zambon S.p.A., c/o Camargo Pharmaceutical Services,
LLC, 9825 Kenwood Rd., Suite 203, Cincinnati, OH
45242.
Technology Organized, LLC, 9191 Point Replete Dr., Fort
Belvoir, VA 22060.
Sovereign Pharmaceuticals, LLC, 7590 Sand St., Fort
Worth, TX 76118.
Zydus Pharmaceuticals USA, Inc., 73 Route 31 North, Pennington, NJ 08534.
ANDA 091180 ........
ANDA 203176 ........
Nevirapine Tablets USP, 200 mg ..........................................
ANDA 204900 ........
Amlodipine Besylate Tablets USP, EQ 2.5 mg base, EQ 5
mg base, and EQ 10 mg base.
Clozapine Tablets USP, 25 mg, 50 mg, 100 mg, and 200
mg.
ANDA 209480 ........
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of May 11, 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 May 11, 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: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07440 Filed 4–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1095]
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
amozie on DSK30RV082PROD with NOTICES
SUMMARY:
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requesting that any consumer
organizations interested in participating
in the selection of voting and/or
nonvoting consumer representatives to
serve on its advisory committees or
panels notify FDA in writing. FDA is
also requesting nominations for voting
and/or nonvoting consumer
representatives to serve on advisory
committees and/or panels for which
vacancies currently exist or are expected
to occur in the near future. Nominees
recommended to serve as a voting or
nonvoting consumer representative may
be self-nominated or may be nominated
by a consumer organization.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees, and therefore encourages
nominations of appropriately qualified
candidates from these groups.
DATES: Any consumer organization
interested in participating in the
selection of an appropriate voting or
nonvoting member to represent
consumer interests on an FDA advisory
committee or panel may send a letter or
email stating that interest to FDA (see
ADDRESSES) by May 11, 2018, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by May 11, 2018.
Nominations will be accepted for
current vacancies and for those that will
or may occur through July 31, 2018.
ADDRESSES: All statements of interest
from consumer organizations interested
in participating in the selection process
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
and consumer representative
nominations should be submitted
electronically to ACOMSSubmissions@
fda.hhs.gov, by mail or delivery service
to Advisory Committee Oversight and
Management Staff, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002, or by
Fax: 301–847–8640.
Consumer representative nominations
should be submitted electronically by
logging into the FDA Advisory
Committee Membership Nomination
Portal: https://www.accessdata.fda.gov/
scripts/FACTRSPortal/FACTRS/
index.cfm; by mail or delivery service to
Advisory Committee Oversight and
Management Staff, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002; or by
Fax: 301–847–8640. Additional
information about becoming a member
of an FDA advisory committee can also
be obtained by visiting FDA’s website at
https://www.fda.gov/
AdvisoryCommittees/default.htm.
For
questions relating to participation in the
selection process: Kimberly Hamilton,
Advisory Committee Oversight and
Management Staff (ACOMS), Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002, 301–
796–8220, email: kimberly.hamilton@
fda.hhs.gov.
For questions relating to specific
advisory committees or panels, contact
the appropriate contact person listed in
table 1.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\11APN1.SGM
11APN1
]]>Agencies
[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15577-15578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07440]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1336]
Oxford Pharmaceuticals, LLC, et al.; Withdrawal of Approval of 18
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 18 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 May 11, 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 040252.............. Carisoprodol and Oxford
Aspirin Tablets USP, Pharmaceuticals,
200 milligrams (mg)/ LLC, 301 Leaf Lake
325 mg. Pkwy., Birmingham,
AL 35211.
ANDA 040283.............. Carisoprodol, Aspirin, Do.
and Codeine Phosphate
Tablets USP, 200 mg/
325 mg/16 mg.
ANDA 061214.............. Tetracycline Roxane Laboratories,
Hydrochloride (HCl) Inc., 1809 Wilson
Capsules USP, 250 mg Rd., Columbus, OH
and 500 mg. 43228.
ANDA 061682.............. Tetracycline HCl Mylan Pharmaceuticals
Tablets, 500 mg. Inc., P.O. Box 4293,
Morgantown, WV
26505.
ANDA 062212.............. Totacillin (ampicillin/ GlaxoSmithKline, Five
ampicillin Moore Dr., P.O. Box
trihydrate) Capsules, 13398, Research
Equivalent to (EQ) Triangle Park, NC
250 mg base and EQ 27709.
500 mg base.
ANDA 062654.............. Rocephin (ceftriaxone Hoffman La-Roche,
sodium) for Inc., c/o Genentech,
Injection, EQ 500 mg Inc., 1 DNA Way, MS
base/vial, EQ 1 gram 241B, South San
(g) base/vial, and EQ Francisco, CA 94080.
2 g base/vial.
ANDA 062680.............. Oxacillin Sodium for ACS Dobfar S.p.A., c/
Injection (Pharmacy o Interchem Corp.,
Bulk Package). 120 Route 17 North,
Paramus, NJ 07653.
ANDA 065124.............. Cefotaxime for Lupin Ltd., c/o Lupin
Injection USP, EQ 500 Pharmaceuticals,
mg base/vial, EQ 1 g Inc., 111 South
base/vial, and EQ 2 g Calvert St.,
base/vial. Harborplace Tower,
24th Floor,
Baltimore, MD 21202.
ANDA 065263.............. Ceftriaxone for Do.
Injection USP, EQ 10
g base/vial (Pharmacy
Bulk Package).
ANDA 074845.............. Diltiazem HCl Extended- Biovail Corp.
Release Capsules USP, International,
60 mg, 90 mg, and 120 Subsidiary of
mg. Valeant
Pharmaceuticals
North America, LLC,
400 Somerset
Corporate Blvd.,
Bridgewater, NJ
08807.
[[Page 15578]]
ANDA 077173.............. Ondansetron Injection Sun Pharmaceutical
USP, EQ 2 mg base/ Industries Ltd., c/o
milliliter (mL). Sun Pharmaceutical
Industries, Inc., 2
Independence Way,
Princeton, NJ 08540.
ANDA 078598.............. Ciprofloxacin Amring
Ophthalmic Solution Pharmaceuticals,
USP, EQ 0.3% base. Inc., 1235 Westlakes
Dr., Suite 205,
Berwyn, PA 19312.
ANDA 078805.............. Irinotecan HCl Sun Pharma Global
Injection, 20 mg/mL. FZE, c/o Sun
Pharmaceutical
Industries, Inc., 2
Independence Way,
Princeton, NJ 08540.
ANDA 086024.............. Capital and Codeine Valeant
(acetaminophen and Pharmaceuticals
codeine phosphate) North America, LLC,
Oral Suspension USP, 400 Somerset
120 mg/12 mg per 5 mL. Corporate Blvd.,
Bridgewater, NJ
08807.
ANDA 091180.............. Dorzolamide HCl and Zambon S.p.A., c/o
Timolol Maleate Camargo
Ophthalmic Solution, Pharmaceutical
EQ 2% base/EQ 0.5% Services, LLC, 9825
base. Kenwood Rd., Suite
203, Cincinnati, OH
45242.
ANDA 203176.............. Nevirapine Tablets Technology Organized,
USP, 200 mg. LLC, 9191 Point
Replete Dr., Fort
Belvoir, VA 22060.
ANDA 204900.............. Amlodipine Besylate Sovereign
Tablets USP, EQ 2.5 Pharmaceuticals,
mg base, EQ 5 mg LLC, 7590 Sand St.,
base, and EQ 10 mg Fort Worth, TX
base. 76118.
ANDA 209480.............. Clozapine Tablets USP, Zydus Pharmaceuticals
25 mg, 50 mg, 100 mg, USA, Inc., 73 Route
and 200 mg. 31 North,
Pennington, NJ
08534.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of May
11, 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 May 11, 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: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07440 Filed 4-10-18; 8:45 am]
BILLING CODE 4164-01-P
