Watson Laboratories, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications, 5828-5829 [2022-02053]
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Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices
Application No.
Drug
Applicant
NDA 020037 ........................
Voltaren (diclofenac sodium) Ophthalmic Solution, 0.1%
NDA 021169 ........................
Razadyne (galantamine hydrobromide) Tablets, EQ 4
mg base, EQ 8 mg base, and EQ 12 mg base.
Starlix (nateglinide) Tablets, 60 mg, and 120 mg ..........
Fortical (calcitonin-salmon recombinant) Nasal Spray,
200 International Units/Spray.
Sarafem (fluoxetine HCl) Tablets, EQ 10 mg base, EQ
15 mg base, and EQ 20 mg base.
Novartis Pharmaceuticals Corp., 1 Health Plaza, East
Hanover, NJ 07936–1080.
Janssen Research & Development, LLC, 1125 TrentonHarbourton Rd., Titusville, NJ 08560.
Novartis Pharmaceuticals Corp.
Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr.,
Maple Grove, MN 55369.
Allergan Pharmaceuticals International Ltd., c/o
Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ
07940.
LEO Laboratories Ltd., c/o LEO Pharma Inc., 7 Giralda
Farms, Madison, NJ 07940.
Recro Gainesville LLC, 1300 Gould Dr., Gainesville,
GA 30504.
NDA 021204 ........................
NDA 021406 ........................
NDA 021860 ........................
NDA 202833 ........................
Picato (ingenol mebutate) Gel, 0.015%, and 0.05% ......
NDA 202880 ........................
Zohydro ER (hydrocodone bitartrate) Extended-release
Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and
50 mg.
Khedezla (desvenlafaxine) Extended-Release Tablets,
50 mg, and 100 mg.
Cetylev (acetylcysteine) Effervescent Tablets, 500 mg,
and 2.5 g.
NDA 204683 ........................
NDA 207916 ........................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of March 4,
2022. 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application is withdrawn, including any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 March 4, 2022
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0074]
Watson Laboratories, Inc., et al.;
Withdrawal of Approval of Eight
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of eight
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.
[FR Doc. 2022–02059 Filed 2–1–22; 8:45 am]
DATES:
BILLING CODE 4164–01–P
jspears on DSK121TN23PROD with NOTICES1
Osmotica Pharmaceutical US LLC, 400 Crossing Blvd.,
Bridgewater, NJ 08807.
Arbor Pharmaceuticals, LLC, 6 Concourse Pkwy., Suite
1800, Atlanta, GA 30328.
SUMMARY:
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:
Approval is withdrawn as of
March 4, 2022.
Application No.
Drug
Applicant
ANDA 075152 ........
Diclofenac Potassium Tablets, 50 milligrams (mg) ................
ANDA 091376 ........
ANDA 091471 ........
Topotecan Hydrochloride (HCl) for Injection, Equivalent to
(EQ) 4 mg base/vial.
Efavirenz Tablets, 600 mg .....................................................
ANDA 200463 ........
Itraconazole Capsules, 100 mg .............................................
ANDA 202395 ........
ANDA 203170 ........
Ziprasidone HCl Capsules, EQ 20 mg base, EQ 40 mg
base, EQ 60 mg base, and EQ 80 mg base.
Docetaxel Injection, 40 mg/milliliter ........................................
Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace
Pkwy., Bldg. A, Parsippany, NJ 07054.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
Mylan Pharmaceuticals Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505.
Mylan Pharmaceuticals Inc., a Viatris Company, 781 Chestnut Ridge Rd., Morgantown, WV 26504.
Do.
ANDA 203574 ........
Mesalamine Delayed Release Tablets, 1.2 grams ................
ANDA 208177 ........
Atazanavir Sulfate Capsules, EQ 150 mg base, EQ 200 mg
base, and EQ 300 mg base.
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Jiangsu Hengrui Pharmaceuticals Co., Ltd., U.S. Agent,
eVenus Pharmaceutical Laboratories Inc., 506 Carnegie
Center, Suite 100, Princeton, NJ 08540.
Mylan Pharmaceuticals Inc., a Viatris Company, 781 Chestnut Ridge Rd., Morgantown, WV 26504.
Do.
E:\FR\FM\02FEN1.SGM
02FEN1
Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of March 4,
2022. 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 March 4, 2022
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: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02053 Filed 2–1–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of
Meeting
jspears on DSK121TN23PROD with NOTICES1
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Literature Selection
Technical Review Committee.
The meeting is devoted to the review
and evaluation of journals for potential
indexing by the National Library of
Medicine and will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(9)(B), Title 5 U.S.C., as
amended. Premature disclosure of the
titles of the journals as potential titles to
be indexed by the National Library of
Medicine, the discussions, and the
presence of individuals associated with
these publications could significantly
frustrate the review and evaluation of
individual journals.
Name of Committee: Literature Selection
Technical Review Committee.
Date: June 23–24, 2022.
Time: 9:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate journals
as potential titles to be indexed by the
National Library of Medicine.
Place: Virtual Meeting.
Contact Person: Dianne Babski, Associate
Director, Division of Library Operations,
National Library of Medicine, 8600 Rockville
Pike, Building 38, Room 4S404, Bethesda,
MD 20894, 301–827–4729, babskid@
mail.nih.gov.
VerDate Sep<11>2014
21:31 Feb 01, 2022
Jkt 256001
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS).
Dated: January 28, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–02128 Filed 2–1–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group; Imaging Guided
Interventions and Surgery Study Section.
Date: March 3–4, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Yuanna Cheng, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
MSC 7814, Bethesda, MD 20892, (301) 435–
1195, Chengy5@csr.nih.gov.
Name of Committee: Biology of
Development and Aging Integrated Review
Group; Drug Discovery and Molecular
Pharmacology Study Section.
Date: March 3–4, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jeffrey Smiley, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6194,
MSC 7804, Bethesda, MD 20892, 301–594–
7945, smileyja@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
PO 00000
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Fellowships: Chemistry, Biochemistry and
Biophysics A.
Date: March 3, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shan Wang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 496–4390, shan.wang@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Hypersensitivity, Allergies and Mucosal
Immunology (HAMI).
Date: March 3–4, 2022.
Time: 9:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Deborah Hodge, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4207,
MSC 7812, Bethesda, MD 20892, (301) 435–
1238, hodged@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AREA/
REAP: Cardiovascular and Respiratory
Sciences.
Date: March 3, 2022.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Sara Ahlgren, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, RM 4136,
Bethesda, MD 20892, 301–435–0904,
sara.ahlgren@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Antiviral
Drug Discovery and Mechanisms of
Resistance.
Date: March 7–8, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shinako Takada, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, 301–402–9448, shinako.takada@
nih.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Infectious Diseases, Reproductive Health,
Asthma and Pulmonary Conditions Study
Section.
Date: March 7–8, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\02FEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 22 (Wednesday, February 2, 2022)]
[Notices]
[Pages 5828-5829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02053]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0074]
Watson Laboratories, Inc., et al.; Withdrawal of Approval of
Eight 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 eight 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 March 4, 2022.
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 075152............. Diclofenac Potassium Watson Laboratories,
Tablets, 50 Inc. (an indirect,
milligrams (mg). wholly owned
subsidiary of Teva
Pharmaceuticals USA,
Inc.), 400 Interpace
Pkwy., Bldg. A,
Parsippany, NJ 07054.
ANDA 091376............. Topotecan Fresenius Kabi USA,
Hydrochloride (HCl) LLC, Three Corporate
for Injection, Dr., Lake Zurich, IL
Equivalent to (EQ) 4 60047.
mg base/vial.
ANDA 091471............. Efavirenz Tablets, 600 Mylan Pharmaceuticals
mg. Inc., a Viatris
Company, 3711 Collins
Ferry Rd.,
Morgantown, WV 26505.
ANDA 200463............. Itraconazole Capsules, Mylan Pharmaceuticals
100 mg. Inc., a Viatris
Company, 781 Chestnut
Ridge Rd.,
Morgantown, WV 26504.
ANDA 202395............. Ziprasidone HCl Do.
Capsules, EQ 20 mg
base, EQ 40 mg base,
EQ 60 mg base, and EQ
80 mg base.
ANDA 203170............. Docetaxel Injection, Jiangsu Hengrui
40 mg/milliliter. Pharmaceuticals Co.,
Ltd., U.S. Agent,
eVenus Pharmaceutical
Laboratories Inc.,
506 Carnegie Center,
Suite 100, Princeton,
NJ 08540.
ANDA 203574............. Mesalamine Delayed Mylan Pharmaceuticals
Release Tablets, 1.2 Inc., a Viatris
grams. Company, 781 Chestnut
Ridge Rd.,
Morgantown, WV 26504.
ANDA 208177............. Atazanavir Sulfate Do.
Capsules, EQ 150 mg
base, EQ 200 mg base,
and EQ 300 mg base.
------------------------------------------------------------------------
[[Page 5829]]
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
4, 2022. 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 March 4, 2022 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: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02053 Filed 2-1-22; 8:45 am]
BILLING CODE 4164-01-P
