Pfizer Inc., et.al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications, 38144-38145 [2020-13661]
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Federal Register / Vol. 85, No. 123 / Thursday, June 25, 2020 / Notices
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jbell on DSKJLSW7X2PROD with NOTICES
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Application No.
Drug
ANDA 060567 ....
Lidocaine Hydrochloride (HCl); Oxytetracycline Injection, 2%;
50 milligrams (mg)/milliters (mL), and 2%; 125 mg/mL.
Gentamicin Sulfate Injection, Equivalent to (EQ) 10 mg base/
mL.
Clindamycin Phosphate Solution, EQ 1% base ......................
ANDA 062612 ....
ANDA 062811 ....
ANDA 063333 ....
VerDate Sep<11>2014
Jkt 250001
PO 00000
Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13746 Filed 6–24–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1528]
Pfizer Inc., et.al.; Withdrawal of
Approval of 12 Abbreviated New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 12 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applications be withdrawn.
DATES: Approval is withdrawn as of July
27, 2020.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
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 § 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.
SUMMARY:
Applicant
Cefoperazone Sodium for Injection, EQ 1 gram (gm) base/
vial.
19:15 Jun 24, 2020
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Frm 00037
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Pfizer Inc., 235 East 42nd St., New York, NY 10017.
Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL
60045.
G&W Laboratories Inc., 301 Helen St., South Plainfield, NJ
07080.
Pfizer Inc.
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Federal Register / Vol. 85, No. 123 / Thursday, June 25, 2020 / Notices
Application No.
Drug
Applicant
ANDA 078288 ....
Ondansetron HCl Injection, EQ 2 mg base/mL .......................
ANDA 080426 ....
Hydrocortisone Lotion, 0.5% ....................................................
ANDA 090813 ....
Levetiracetam Injection, 500 mg/5 mL (100 mg/mL) ...............
ANDA 201751 ....
ANDA 202684 ....
Articaine HCl; Epinephrine Bitartrate Injection, 4%; EQ
0.0085 mg base/1.7 mL; 4%; EQ 0.005 mg base/mL.
Levonorgestrel Tablets, 0.75 mg .............................................
Baxter Healthcare Corp., 1 Baxter Parkway, Deerfield, IL
60015.
Bausch Health Americas Inc., 400 Somerset Corporate Blvd.,
Bridgewater, NJ 08807.
Fresenius Kabi USA, LLC., Three Corporate Dr., Lake Zurich, IL 60047.
Hansamed Ltd., 4761 Tara Ct., West Bloomfield, MI 48323.
ANDA 204796 ....
Capreomycin Sulfate for Injection, EQ 1 gm base/vial ............
ANDA 205943 ....
Ethinyl Estradiol; Levonorgestrel Tablets, 0.02 mg, 0.15 mg;
0.025 mg, 0.15 mg; 0.03 mg, 0.15 mg; 0.01 mg, N/A.
Fluoxetine HCl Tablets, EQ 60 mg base .................................
ANDA 212191 ....
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of July 27, 2020.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms inadvertently missing
from the table. 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 July 27, 2020, 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: June 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13661 Filed 6–24–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
jbell on DSKJLSW7X2PROD with NOTICES
38145
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
National Advisory Committee on Rural
Health and Human Services
(NACRHHS) has scheduled a public
meeting. Information about NACRHHS
SUMMARY:
VerDate Sep<11>2014
19:15 Jun 24, 2020
Jkt 250001
Alvogen PB Research and Development LLC, U.S. Agent for
Lotus Pharmaceutical Co., Ltd. Nantou Plant, 44 Whippany
Rd., Suite 300, Morristown, NJ 07960.
Hisun Pharmaceuticals USA, Inc., U.S. Agent for Hisun Pharmaceutical (Hangzhou) Co., Ltd., 200 Crossing Blvd., 2nd
Floor, Bridgewater, NJ 08807.
Lupin Pharmaceuticals, Inc., 111 South Calvert St., Baltimore, MD 21202.
G&W Laboratories, Inc.
and the agenda for this meeting can be
found on the NACRHHS website at
https://www.hrsa.gov/advisorycommittees/rural-health/.
DATES: July 30, 2020, 12:00 p.m.–5:00
p.m. Eastern Time.
ADDRESSES: The meeting scheduled on
July 30, 2020, will be held by
teleconference/webinar. Instructions for
joining the meeting remotely will be
posted on the NACRHHS website 30
calendar days before the date of the
meeting. For meeting information
updates, go to the NACRHHS website
meeting page at https://www.hrsa.gov/
advisory-committees/rural-health/
meetings/.
FOR FURTHER INFORMATION CONTACT:
Steven Hirsch, Administrative
Coordinator at the Federal Office of
Rural Health Policy, HRSA, 5600
Fishers Lane, Rockville, Maryland
20857; 301–443–7322; or shirsch@
hrsa.gov.
and are seen as an essential part of the
economic fabric.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Requests to submit a written
statement or make oral comments to
NACRHHS should be sent to Steven
Hirsch, using the contact information
above, at least 3 business days prior to
the meeting.
Individuals who plan to attend the
teleconference/webinar meeting and
need special assistance or another
reasonable accommodation should
notify Steven Hirsch at the address and
phone number listed above at least 10
business days prior to the meeting.
SUPPLEMENTARY INFORMATION:
NACRHHS provides advice and
recommendations to the Secretary of
HHS (Secretary) on policy, program
development, and other matters of
significance concerning both rural
health and rural human services.
At this meeting, NACRHHS will
discuss the development of a vision
statement that emphasizes rural
community transformation, sustainable
services, and resiliency. By focusing on
this vision, NACRHHS will define what
it wants to accomplish and how to
articulate a policy framework that
informs the HHS leadership and
empowers rural communities. The
intent is to use this process to create a
path forward that would help
NACRHHS identify policies that
empower rural communities to ensure
access to core health and human service
needs that are focused on local residents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Frm 00038
Fmt 4703
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Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–13670 Filed 6–24–20; 8:45 am]
BILLING CODE 4165–15–P
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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]]>Agencies
[Federal Register Volume 85, Number 123 (Thursday, June 25, 2020)]
[Notices]
[Pages 38144-38145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13661]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1528]
Pfizer Inc., et.al.; Withdrawal of Approval of 12 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 12 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 July 27, 2020.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [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 060567............ Lidocaine Hydrochloride Pfizer Inc., 235 East
(HCl); Oxytetracycline 42nd St., New York,
Injection, 2%; 50 NY 10017.
milligrams (mg)/
milliters (mL), and
2%; 125 mg/mL.
ANDA 062612............ Gentamicin Sulfate Hospira, Inc., 275
Injection, Equivalent North Field Dr.,
to (EQ) 10 mg base/mL. Bldg. H1, Lake
Forest, IL 60045.
ANDA 062811............ Clindamycin Phosphate G&W Laboratories Inc.,
Solution, EQ 1% base. 301 Helen St., South
Plainfield, NJ 07080.
ANDA 063333............ Cefoperazone Sodium for Pfizer Inc.
Injection, EQ 1 gram
(gm) base/vial.
[[Page 38145]]
ANDA 078288............ Ondansetron HCl Baxter Healthcare
Injection, EQ 2 mg Corp., 1 Baxter
base/mL. Parkway, Deerfield,
IL 60015.
ANDA 080426............ Hydrocortisone Lotion, Bausch Health Americas
0.5%. Inc., 400 Somerset
Corporate Blvd.,
Bridgewater, NJ
08807.
ANDA 090813............ Levetiracetam Fresenius Kabi USA,
Injection, 500 mg/5 mL LLC., Three Corporate
(100 mg/mL). Dr., Lake Zurich, IL
60047.
ANDA 201751............ Articaine HCl; Hansamed Ltd., 4761
Epinephrine Bitartrate Tara Ct., West
Injection, 4%; EQ Bloomfield, MI 48323.
0.0085 mg base/1.7 mL;
4%; EQ 0.005 mg base/
mL.
ANDA 202684............ Levonorgestrel Tablets, Alvogen PB Research
0.75 mg. and Development LLC,
U.S. Agent for Lotus
Pharmaceutical Co.,
Ltd. Nantou Plant, 44
Whippany Rd., Suite
300, Morristown, NJ
07960.
ANDA 204796............ Capreomycin Sulfate for Hisun Pharmaceuticals
Injection, EQ 1 gm USA, Inc., U.S. Agent
base/vial. for Hisun
Pharmaceutical
(Hangzhou) Co., Ltd.,
200 Crossing Blvd.,
2nd Floor,
Bridgewater, NJ
08807.
ANDA 205943............ Ethinyl Estradiol; Lupin Pharmaceuticals,
Levonorgestrel Inc., 111 South
Tablets, 0.02 mg, 0.15 Calvert St.,
mg; 0.025 mg, 0.15 mg; Baltimore, MD 21202.
0.03 mg, 0.15 mg; 0.01
mg, N/A.
ANDA 212191............ Fluoxetine HCl Tablets, G&W Laboratories, Inc.
EQ 60 mg base.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of July
27, 2020. Approval of each entire application is withdrawn, including
any strengths and dosage forms inadvertently missing from the table.
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 July 27, 2020, 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: June 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13661 Filed 6-24-20; 8:45 am]
BILLING CODE 4164-01-P
