Roerig Division of Pfizer Inc., et.al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications, 44096 [2020-15727]
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44096
Federal Register / Vol. 85, No. 140 / Tuesday, July 21, 2020 / Notices
2021. Since the project’s
implementation, the grantee has made
satisfactory progress toward its
approved work plan.
This supplemental funding is
intended to enhance NCOA’s existing
work—enabling them to provide
responsive support for communitybased organizations during the COVID–
19 pandemic by piloting the remote/
virtual delivery of falls prevention
interventions.
As a well-established and trusted
organization in the aging and disability
networks, NCOA is uniquely positioned
to complete the work called for under
this project. Their current grant has two
primary goals: (1) To provide public
education on the risk of falls and how
to prevent them; and (2) support the
implementation and dissemination of
evidence-based falls prevention
programs. To accomplish these goals,
NCOA serves as the national leader in
falls prevention, reaching millions of
professionals, older adults, individuals
with disabilities, and their families each
year through Falls Prevention
Awareness Day and other public
awareness activities and events. They
also provide technical assistance for
organizations implementing falls
prevention programs, including one-onone consultation, national conferences,
and webinars. They have a
comprehensive, interactive website with
tools and resources, including—but not
limited to—issues briefs, tip sheets,
Dated: July 8, 2020.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2020–15280 Filed 7–20–20; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1227]
Roerig Division of Pfizer Inc., et.al.;
Withdrawal of Approval of 10
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 10 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applications be withdrawn.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Approval is withdrawn as of
August 20, 2020.
DATES:
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.
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:
Application No.
Drug
Applicant
ANDA 060709 .........
Oleandomycin Injection .........................................................
ANDA 061087 .........
ANDA 061943 .........
Benzocaine, Oxytetracycline Hydrochloride (HCl), and Polymyxin B Sulfate Otic Solution.
Tetracycline HCl Capsules, 250 milligrams (mg) and 500
mg.
Chloramphenicol Ophthalmic Solution, 0.5% ........................
ANDA 062175 .........
ANDA 062215 .........
ANDA 076203 .........
Tetracycline HCl Capsules, 250 mg ......................................
Oxytetracycline HCl Capsules ...............................................
Ribavirin Capsules, 200 mg ..................................................
ANDA 077456 .........
ANDA 084669 .........
Ribavirin Tablets, 200 mg, 400 mg, and 600 mg .................
Chlorpropamide Tablets, 250 mg ..........................................
ANDA 201750 .........
Articaine HCI and Epinephrine Bitartrate for Injection, 4%;
Equivalent to (EQ) 0.017 mg base/1.7 milliliters (mL);
(4%; EQ 0.01 mg base/mL).
Roerig Division of Pfizer Inc., 235 East 42nd St., New York,
NY 10017.
Pfizer Laboratories, Division of Pfizer Inc., 235 East 42nd
St., New York, NY 10017.
Warner Chilcott Division of Warner Lambert-Pfizer, Inc.,
235 East 42nd St., New York, NY 10017.
Lederle Laboratories, Division of American Cyanamid Co.,
1 Cyanamid Plaza, Wayne, NJ 07470.
Warner Chilcott Division of Warner Lambert-Pfizer, Inc.
Lederle Laboratories, Division of American Cyanamid Co.
Kadmon Pharmaceuticals, LLC, 119 Commonwealth Dr.,
Warrendale, PA 15086.
Do.
Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO
80038.
Hansamed Ltd., 4761 Tara Ct., West Bloomfield, MI 48323.
ANDA 061725 .........
jbell on DSKJLSW7X2PROD with NOTICES
policy and practice models, and
toolkits. They have also presented to the
aging and disability networks locally
and on a national level, and have
developed substantive partnerships
with program developers, organizations,
universities.
Establishing an entirely new grant
project at this time would be potentially
disruptive to the work needed to ensure
the continued availability of falls
prevention programs. If this supplement
were not provided, ACL grantees and
the hundreds community-based
organizations across the nation who
provide many of these falls prevention
interventions would be unable to do so
due to the COVID–19 pandemic.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of August 20,
2020. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
VerDate Sep<11>2014
17:42 Jul 20, 2020
Jkt 250001
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 August 20, 2020
may continue to be dispensed until the
inventories have been depleted or the
PO 00000
Frm 00058
Fmt 4703
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drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: July 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–15727 Filed 7–20–20; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 85, Number 140 (Tuesday, July 21, 2020)]
[Notices]
[Page 44096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15727]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1227]
Roerig Division of Pfizer Inc., et.al.; Withdrawal of Approval of
10 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 10 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 August 20, 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 060709............... Oleandomycin Roerig Division of
Injection. Pfizer Inc., 235
East 42nd St., New
York, NY 10017.
ANDA 061087............... Benzocaine, Pfizer Laboratories,
Oxytetracycline Division of Pfizer
Hydrochloride (HCl), Inc., 235 East 42nd
and Polymyxin B St., New York, NY
Sulfate Otic 10017.
Solution.
ANDA 061725............... Tetracycline HCl Warner Chilcott
Capsules, 250 Division of Warner
milligrams (mg) and Lambert-Pfizer,
500 mg. Inc., 235 East 42nd
St., New York, NY
10017.
ANDA 061943............... Chloramphenicol Lederle Laboratories,
Ophthalmic Solution, Division of American
0.5%. Cyanamid Co., 1
Cyanamid Plaza,
Wayne, NJ 07470.
ANDA 062175............... Tetracycline HCl Warner Chilcott
Capsules, 250 mg. Division of Warner
Lambert-Pfizer, Inc.
ANDA 062215............... Oxytetracycline HCl Lederle Laboratories,
Capsules. Division of American
Cyanamid Co.
ANDA 076203............... Ribavirin Capsules, Kadmon
200 mg. Pharmaceuticals,
LLC, 119
Commonwealth Dr.,
Warrendale, PA
15086.
ANDA 077456............... Ribavirin Tablets, Do.
200 mg, 400 mg, and
600 mg.
ANDA 084669............... Chlorpropamide Sandoz Inc., 2555 W.
Tablets, 250 mg. Midway Blvd.,
Broomfield, CO
80038.
ANDA 201750............... Articaine HCI and Hansamed Ltd., 4761
Epinephrine Tara Ct., West
Bitartrate for Bloomfield, MI
Injection, 4%; 48323.
Equivalent to (EQ)
0.017 mg base/1.7
milliliters (mL);
(4%; EQ 0.01 mg base/
mL).
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
August 20, 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 August 20, 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: July 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15727 Filed 7-20-20; 8:45 am]
BILLING CODE 4164-01-P
