GlaxoSmithKline, LLC, et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications, 49102-49103 [2018-21199]
Download as PDF
<![CDATA[
49102
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices
person on or before November 1, 2018.
Oral presentations from the public will
be scheduled between approximately
12:45 p.m. to 1:45 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 24, 2018. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 25, 2018.
Closed Committee Deliberations: On
November 8, 2018, from 1:50 p.m. to
2:45 p.m., the meeting will be closed to
permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). The recommendations of the
advisory committee regarding the
progress of the investigator’s research
will, along with other information, be
used in making personnel and staffing
decisions regarding individual
scientists.
We believe that public discussion of
these recommendations on individual
scientists would constitute an
unwarranted invasion of personal
privacy.
Dated: September 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21137 Filed 9–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3569]
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 24 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applications be withdrawn.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Approval is withdrawn as of
October 29, 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
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:
GlaxoSmithKline, LLC, et al.;
Withdrawal of Approval of 24
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Application No.
Drug
Applicant
ANDA 061336 ....
GlaxoSmithKline, LLC, Five Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709.
ACS Dobfar S.p.A., c/o Interchem Corp., 120 Rte. 17 North,
Paramus, NJ 07652.
ANDA 062615 ....
Bactocill (oxacillin sodium) Capsules, Equivalent to (EQ) 250
milligrams (mg) base and EQ 500 mg base.
Kefzol (cefazolin) for Injection USP, EQ 250 mg base/vial,
EQ 500 mg base/vial, EQ 1 gram (g) base/vial, EQ 10 g
base/vial, and EQ 20 g base/vial.
Nystatin Vaginal Inserts USP, 100,000 units ...........................
ANDA 063304 ....
Clindamycin Phosphate Topical Solution USP, EQ 1% base
ANDA 065001 ....
Cefuroxime for Injection USP, EQ 750mg base/vial and EQ
1.5 g base/vial.
Cefuroxime for Injection USP, EQ 7.5 g base/vial (Pharmacy
Bulk Package).
Ibuprofen Tablets USP, 300 mg, 400 mg, and 600 mg ..........
ANDA 061773 ....
ANDA 065002 ....
ANDA 070736 ....
ANDA 071202 ....
amozie on DSK3GDR082PROD with NOTICES1
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Serina HunterThomas at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at:
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
ANDA 071847 ....
ANDA 071848 ....
ANDA 072629 ....
Sensorcaine—MPF Spinal (bupivacaine hydrochloride (HCl))
in Dextrose Injection 8.25% USP, 0.75%.
Nitroglycerin in Dextrose 5% Injection, 10 mg/100 milliliter
(mL).
Nitroglycerin in Dextrose 5% Injection, 20 mg/100 mL ...........
Nitroglycerin in Dextrose 5% Injection, 40 mg/100 mL ...........
Albuterol Tablets USP, EQ 2 mg base ....................................
ANDA 074991 ....
Loperamide HCl Oral Solution, 1 mg/5 mL .............................
ANDA 071846 ....
VerDate Sep<11>2014
19:22 Sep 27, 2018
Jkt 244001
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Odyssey Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc.,
6451 Main St., Morton Grove, IL 60053.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
Do.
Aurolife Pharma, LLC, 279 Princeton Hightstown Rd., East
Windsor, NJ 08520.
Fresenius Kabi USA, LLC.
Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL
60045.
Do.
Do.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA Inc., 425 Privet Rd., Horsham, PA 19044.
Duramed Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
E:\FR\FM\28SEN1.SGM
28SEN1
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices
Application No.
Drug
Applicant
ANDA 077312 ....
Par Pharmaceutical, Inc., One Ram Ridge Rd., Chestnut
Ridge, NY 10977.
ANDA 077853 ....
Fentanyl Citrate Troche/Lozenge, EQ 0.2 mg base, EQ 0.4
mg base, EQ 0.6 mg base, EQ 0.8 mg base, EQ 1.2 mg,
and EQ 1.6 mg base.
Metformin HCl Tablets USP, 500 mg, 850 mg, and 1 g .........
ANDA 080355 ....
Hydrocortisone Tablets USP, 20 mg .......................................
ANDA 080377 ....
ANDA 087100 ....
ANDA 087211 ....
Lidocaine HCl with Epinephrine Injection, 1%; 0.01 mg/mL
and 2%; 0.01 mg/mL.
Chlorthalidone Tablets USP, 25 mg ........................................
Methocarbamol and Aspirin Tablets, 400 mg/325 mg .............
ANDA 090184 ....
Podofilox Topical Solution, 0.5% .............................................
ANDA 202002 ....
Imiquimod Cream, 5% .............................................................
ANDA 203247 ....
Sodium Fluoride F–18 Injection, 10–200 millicurie (mCi)/mL ..
ANDA 203933 ....
ANDA 205072 ....
Ammonia N–13 Injection, 3.75–37.5 mCi/mL ..........................
Cefadroxil Capsules USP, EQ 500 mg base ...........................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of October 29,
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 October 29,
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: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
[Docket No. FDA–2018–N–3522]
Use of the Names of Dairy Foods in the
Labeling of Plant-Based Products
Food and Drug Administration,
HHS.
Notice; request for comments.
The Food and Drug
Administration (FDA or we) invites
comments on the labeling of plant-based
products with names that include the
SUMMARY:
VerDate Sep<11>2014
19:22 Sep 27, 2018
Jkt 244001
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 November 27,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 27, 2018.
Comments received by 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.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
names of dairy foods such as ‘‘milk,’’
‘‘cultured milk,’’ ‘‘yogurt,’’ and
‘‘cheese.’’ We are interested in learning
how consumers use these plant-based
products and how they understand
terms such as, for example, ‘‘milk’’ or
‘‘yogurt’’ when included in the names of
plant-based products. We also are
interested in learning whether
consumers are aware of and understand
differences between the basic nature,
characteristics, ingredients, and
nutritional content of plant-based
products and their dairy counterparts.
We are taking this action to inform our
development of an approach to the
labeling of plant-based products that
consumers may substitute for dairy
foods.
Submit either electronic or
written comments on this document by
November 27, 2018.
BILLING CODE 4164–01–P
AGENCY:
Provident Pharmaceutical, Inc., c/o Vintage Pharmaceuticals,
LLC, 1400 Atwater Dr., Malvern, PA 19355.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., Morris Corporate Center III, 400
Interpace Pkwy., Parsippany, NJ 07054.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Bausch & Lomb, Inc., Subsidiary of Valeant Pharmaceuticals
North America, LLC, 400 Somerset Corporate Blvd.,
Bridgewater, NJ 08807.
Strides Pharma Global Pte Ltd., c/o Strides Pharma, Inc., 2
Tower Center Blvd., Suite 1102, East Brunswick, NJ
08816.
University of Texas MD Anderson Cancer Center, Cyclotron
Radiochemistry Facility, 1881 East Rd., Unit 1903, Houston, TX 77054.
Do.
CSPC Ouyi Pharmaceutical Co., Ltd., c/o Megalith Pharmaceuticals, Inc., 9625 Hillside Rd., Rancho Cucamonga, CA
91737.
DATES:
[FR Doc. 2018–21199 Filed 9–27–18; 8:45 am]
amozie on DSK3GDR082PROD with NOTICES1
49103
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\28SEN1.SGM
28SEN1
]]>Agencies
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49102-49103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21199]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3569]
GlaxoSmithKline, LLC, et al.; Withdrawal of Approval of 24
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 24 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 October 29, 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 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 061336............ Bactocill (oxacillin GlaxoSmithKline, LLC,
sodium) Capsules, Five Moore Dr., P.O.
Equivalent to (EQ) 250 Box 13398, Research
milligrams (mg) base Triangle Park, NC
and EQ 500 mg base. 27709.
ANDA 061773............ Kefzol (cefazolin) for ACS Dobfar S.p.A., c/o
Injection USP, EQ 250 Interchem Corp., 120
mg base/vial, EQ 500 Rte. 17 North,
mg base/vial, EQ 1 Paramus, NJ 07652.
gram (g) base/vial, EQ
10 g base/vial, and EQ
20 g base/vial.
ANDA 062615............ Nystatin Vaginal Odyssey
Inserts USP, 100,000 Pharmaceuticals,
units. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 063304............ Clindamycin Phosphate Wockhardt Bio AG, c/o
Topical Solution USP, Morton Grove
EQ 1% base. Pharmaceuticals,
Inc., 6451 Main St.,
Morton Grove, IL
60053.
ANDA 065001............ Cefuroxime for Fresenius Kabi USA,
Injection USP, EQ LLC, Three Corporate
750mg base/vial and EQ Dr., Lake Zurich, IL
1.5 g base/vial. 60047.
ANDA 065002............ Cefuroxime for Do.
Injection USP, EQ 7.5
g base/vial (Pharmacy
Bulk Package).
ANDA 070736............ Ibuprofen Tablets USP, Aurolife Pharma, LLC,
300 mg, 400 mg, and 279 Princeton
600 mg. Hightstown Rd., East
Windsor, NJ 08520.
ANDA 071202............ Sensorcaine--MPF Spinal Fresenius Kabi USA,
(bupivacaine LLC.
hydrochloride (HCl))
in Dextrose Injection
8.25% USP, 0.75%.
ANDA 071846............ Nitroglycerin in Hospira, Inc., 275
Dextrose 5% Injection, North Field Dr.,
10 mg/100 milliliter Bldg. H1, Lake
(mL). Forest, IL 60045.
ANDA 071847............ Nitroglycerin in Do.
Dextrose 5% Injection,
20 mg/100 mL.
ANDA 071848............ Nitroglycerin in Do.
Dextrose 5% Injection,
40 mg/100 mL.
ANDA 072629............ Albuterol Tablets USP, Watson Laboratories,
EQ 2 mg base. Inc., Subsidiary of
Teva Pharmaceuticals
USA Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 074991............ Loperamide HCl Oral Duramed
Solution, 1 mg/5 mL. Pharmaceuticals,
Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
[[Page 49103]]
ANDA 077312............ Fentanyl Citrate Troche/ Par Pharmaceutical,
Lozenge, EQ 0.2 mg Inc., One Ram Ridge
base, EQ 0.4 mg base, Rd., Chestnut Ridge,
EQ 0.6 mg base, EQ 0.8 NY 10977.
mg base, EQ 1.2 mg,
and EQ 1.6 mg base.
ANDA 077853............ Metformin HCl Tablets Provident
USP, 500 mg, 850 mg, Pharmaceutical, Inc.,
and 1 g. c/o Vintage
Pharmaceuticals, LLC,
1400 Atwater Dr.,
Malvern, PA 19355.
ANDA 080355............ Hydrocortisone Tablets Watson Laboratories,
USP, 20 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc., Morris
Corporate Center III,
400 Interpace Pkwy.,
Parsippany, NJ 07054.
ANDA 080377............ Lidocaine HCl with Watson Laboratories,
Epinephrine Injection, Inc., Subsidiary of
1%; 0.01 mg/mL and 2%; Teva Pharmaceuticals
0.01 mg/mL. USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 087100............ Chlorthalidone Tablets Do.
USP, 25 mg.
ANDA 087211............ Methocarbamol and Ivax Pharmaceuticals,
Aspirin Tablets, 400 Inc., Subsidiary of
mg/325 mg. Teva Pharmaceuticals
USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 090184............ Podofilox Topical Bausch & Lomb, Inc.,
Solution, 0.5%. Subsidiary of Valeant
Pharmaceuticals North
America, LLC, 400
Somerset Corporate
Blvd., Bridgewater,
NJ 08807.
ANDA 202002............ Imiquimod Cream, 5%.... Strides Pharma Global
Pte Ltd., c/o Strides
Pharma, Inc., 2 Tower
Center Blvd., Suite
1102, East Brunswick,
NJ 08816.
ANDA 203247............ Sodium Fluoride F-18 University of Texas MD
Injection, 10-200 Anderson Cancer
millicurie (mCi)/mL. Center, Cyclotron
Radiochemistry
Facility, 1881 East
Rd., Unit 1903,
Houston, TX 77054.
ANDA 203933............ Ammonia N-13 Injection, Do.
3.75-37.5 mCi/mL.
ANDA 205072............ Cefadroxil Capsules CSPC Ouyi
USP, EQ 500 mg base. Pharmaceutical Co.,
Ltd., c/o Megalith
Pharmaceuticals,
Inc., 9625 Hillside
Rd., Rancho
Cucamonga, CA 91737.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
October 29, 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 October 29, 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: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21199 Filed 9-27-18; 8:45 am]
BILLING CODE 4164-01-P
