Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of 13 New Drug Applications, 64150-64151 [2020-22402]
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64150
Federal Register / Vol. 85, No. 197 / Friday, October 9, 2020 / Notices
withdrawing approval of nine
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withdrawn.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1866]
Wockhardt Ltd., et al.; Withdrawal of
Approval of Nine Abbreviated New
Drug Applications
AGENCY:
Approval is withdrawn as of
November 9, 2020.
DATES:
Food and Drug Administration,
HHS.
FOR FURTHER INFORMATION CONTACT:
ACTION:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
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.
Application No.
Drug
Applicant
ANDA 040533 ......................
Bethanechol Chloride Tablets, 10 milligrams (mg) .........
ANDA 040534 ......................
ANDA 075015 ......................
Bethanechol Chloride Tablets, 25 mg ............................
Acyclovir Sodium for Injection, Equivalent to (EQ) 500
mg base/vial.
Pamidronate Disodium for Injection, 30 mg/vial, and 90
mg/vial.
Calcitriol Injection, 0.001 mg/milliliter (mL) .....................
Morton Grove Pharmaceuticals Inc./Wockhardt USA
LLC, 6451 Main St., Morton Grove, IL 60053.
Do.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake
Zurich, IL 60047.
Do.
ANDA 075773 ......................
ANDA 076206 ......................
ANDA 076207 ......................
ANDA 077788 ......................
ANDA 077990 ......................
Pamidronate Disodium Injection, 30 mg/10 mL (3 mg/
mL) and 90 mg/mL (9 mg/mL).
Albuterol Sulfate Syrup, EQ 2 mg base/5 mL ................
Zolpidem Tartrate Tablets, 5 mg and 10 mg ..................
ANDA 202410 ......................
Donepezil Hydrochloride Tablets, 23 mg ........................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of November 9,
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 November 9,
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: October 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–22403 Filed 10–8–20; 8:45 am]
Rockwell Medical, Inc., 30142 S. Wixom Rd., Wixom,
MI 48393.
Fresenius Kabi USA, LLC.
VistaPharm, Inc., 7265 Ulmerton Rd., Largo, FL 33771.
Carlsbad Technology, Inc., U.S. Agent for Yung Shin
Pharmaceutical Industrial Co., Ltd., 4761 Tara Ct.,
West Bloomfield, MI 48323.
Hisun Pharmaceutical (Hangzhou) Co., Ltd., U.S.
Agent, Hisun Pharmaceuticals USA, Inc., 200 Crossing Blvd., 2nd floor, Bridgewater, NJ 08807.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1867]
Novartis Pharmaceuticals Corp., et al.;
Withdrawal of Approval of 13 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 13 new drug
applications (NDAs) 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:
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
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:
Approval is withdrawn as of
November 9, 2020.
DATES:
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Federal Register / Vol. 85, No. 197 / Friday, October 9, 2020 / Notices
64151
Application No.
Drug
Applicant
NDA 003290 ........................
Neo-Calglucon (calcium glubionate) Syrup ....................
NDA 009816 ........................
Cortef Acetate S.E.E. Drops (hydrocortisone acetate)
Ophthalmic Solution.
Cortef Acetate (hydrocortisone acetate) Ophthalmic
Ointment, 1.5%.
Optef Drops (hydrocortisone probutate) Ophthalmic Solution, 0.2%.
Mytelase (ambenonium chloride) Tablets, 10 milligrams
(mg).
Norinyl 1 + 50 (norethindrone and mestranol) Tablets, 1
mg/0.05 mg.
Novartis Pharmaceuticals Corp., 1 Health Plaza, East
Hanover, NJ 07936.
Upjohn, a Pfizer Division, 235 East 42nd St., New York,
NY 10017.
Do.
NDA 009817 ........................
NDA 010645 ........................
NDA 010155 ........................
NDA 016659 ........................
NDA 016807 ........................
NDA 017919 ........................
NDA 018768 ........................
NDA 019972 ........................
NDA 021590 ........................
NDA 021664 ........................
NDA 022018 ........................
Thyrolar (liotrix [tetraiodothyronine levothyroxine sodium
(T4) and triiodothyronine liothyronine sodium (T3)])
Tablets, 0.0125 mg/0.0031 mg, 0.025 mg/0.0063 mg,
0.05 mg/0.0125 mg, 0.1 mg/0.025 mg, 0.15 mg/
0.0375 mg, and 0.25 mg/0.0625 mg.
Ortho Novum 1/35 (ethinyl estradiol and norethindrone)
Tablets, 0.035 mg/1 mg.
VePesid (etoposide) Injection, 20 mg/mL .......................
Ocupress (carteolol hydrochloride) Ophthalmic Solution,
1%.
FazaClo (clozapine) Orally Disintegrating Tablets, 12.5
mg, 25 mg, 100 mg, 150 mg, and 200 mg.
Bromday/Xibrom (bromfenac) Ophthalmic Solution,
Equivalent to 0.09%.
Lamivudine and Zidovudine Tablets, 150 mg lamivudine
and 300 mg zidovudine.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of November 9,
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 November 9,
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: October 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–22402 Filed 10–8–20; 8:45 am]
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Sanofi-Aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807.
Actavis Laboratories Ut, Inc. (an indirect, wholly owned
subsidiary of Teva Pharmaceuticals USA, Inc.), 41
Moores Rd., Frazer, PA 19355.
Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ
07940.
Janssen Pharmaceuticals, Inc., 1125 TrentonHarbourton Rd., Titusville, NJ 08560.
Corden Pharma Latina S.p.A., c/o Clinipace Inc., 1434
Spruce St., Suite 100, Boulder, CO 80302.
Novartis Pharmaceuticals Corp.
Jazz Pharmaceuticals Ireland Ltd., c/o Jazz Pharmaceuticals, Inc., 3170 Porter Dr., Palo Alto, CA 94304.
Bausch & Lomb Inc., 400 Somerset Corporate Blvd.,
Bridgewater, NJ 08807.
Pharmacare Ltd., c/o Lachman Consultants Services,
Inc., 1600 Stewart Ave., Suite 604, Westbury, NY
11590.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Jointly Sponsored Predoctoral Training
Program in the Neurosciences (T32).
Date: November 2, 2020.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: David W. Miller, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6140, MSC 9608,
Bethesda, MD 20892–9608, 301–443–9734,
millerda@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
y BRAIN Initiative: Secondary Analysis and
Archiving of BRAIN Initiative Data (R01).
Date: November 5, 2020.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Erin E. Gray, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
6001 Executive Boulevard, NSC 6152B,
Bethesda, MD 20892, 301–402–8152,
erin.gray@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
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[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Notices]
[Pages 64150-64151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22402]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1867]
Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of
13 New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 13 new drug applications (NDAs) 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 November 9, 2020.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [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.
[[Page 64151]]
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 003290.................. Neo-Calglucon Novartis
(calcium Pharmaceuticals
glubionate) Syrup. Corp., 1 Health
Plaza, East
Hanover, NJ 07936.
NDA 009816.................. Cortef Acetate Upjohn, a Pfizer
S.E.E. Drops Division, 235 East
(hydrocortisone 42nd St., New York,
acetate) Ophthalmic NY 10017.
Solution.
NDA 009817.................. Cortef Acetate Do.
(hydrocortisone
acetate) Ophthalmic
Ointment, 1.5%.
NDA 010645.................. Optef Drops Do.
(hydrocortisone
probutate)
Ophthalmic
Solution, 0.2%.
NDA 010155.................. Mytelase (ambenonium Sanofi-Aventis U.S.
chloride) Tablets, LLC, 55 Corporate
10 milligrams (mg). Dr., Bridgewater,
NJ 08807.
NDA 016659.................. Norinyl 1 + 50 Actavis Laboratories
(norethindrone and Ut, Inc. (an
mestranol) Tablets, indirect, wholly
1 mg/0.05 mg. owned subsidiary of
Teva
Pharmaceuticals
USA, Inc.), 41
Moores Rd., Frazer,
PA 19355.
NDA 016807.................. Thyrolar (liotrix Allergan Sales, LLC,
[tetraiodothyronine 5 Giralda Farms,
levothyroxine Madison, NJ 07940.
sodium (T4) and
triiodothyronine
liothyronine sodium
(T3)]) Tablets,
0.0125 mg/0.0031
mg, 0.025 mg/0.0063
mg, 0.05 mg/0.0125
mg, 0.1 mg/0.025
mg, 0.15 mg/0.0375
mg, and 0.25 mg/
0.0625 mg.
NDA 017919.................. Ortho Novum 1/35 Janssen
(ethinyl estradiol Pharmaceuticals,
and norethindrone) Inc., 1125 Trenton-
Tablets, 0.035 mg/1 Harbourton Rd.,
mg. Titusville, NJ
08560.
NDA 018768.................. VePesid (etoposide) Corden Pharma Latina
Injection, 20 mg/mL. S.p.A., c/o
Clinipace Inc.,
1434 Spruce St.,
Suite 100, Boulder,
CO 80302.
NDA 019972.................. Ocupress (carteolol Novartis
hydrochloride) Pharmaceuticals
Ophthalmic Corp.
Solution, 1%.
NDA 021590.................. FazaClo (clozapine) Jazz Pharmaceuticals
Orally Ireland Ltd., c/o
Disintegrating Jazz
Tablets, 12.5 mg, Pharmaceuticals,
25 mg, 100 mg, 150 Inc., 3170 Porter
mg, and 200 mg. Dr., Palo Alto, CA
94304.
NDA 021664.................. Bromday/Xibrom Bausch & Lomb Inc.,
(bromfenac) 400 Somerset
Ophthalmic Corporate Blvd.,
Solution, Bridgewater, NJ
Equivalent to 0.09%. 08807.
NDA 022018.................. Lamivudine and Pharmacare Ltd., c/o
Zidovudine Tablets, Lachman Consultants
150 mg lamivudine Services, Inc.,
and 300 mg 1600 Stewart Ave.,
zidovudine. Suite 604,
Westbury, NY 11590.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
November 9, 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 November 9, 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: October 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22402 Filed 10-8-20; 8:45 am]
BILLING CODE 4164-01-P
