AbbVie Inc., et al.; Withdrawal of Approval of 30 New Drug Applications, 50337-50339 [2022-17534]
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Federal Register / Vol. 87, No. 157 / Tuesday, August 16, 2022 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Board on Radiation and
Worker Health (ABRWH),
Subcommittee for Procedures Reviews
(SPR), National Institute for
Occupational Safety and Health
(NIOSH)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Subcommittee for Procedures
Reviews (SPR) of the Advisory Board on
Radiation and Worker Health (ABRWH
or the Advisory Board). This meeting is
open to the public, but without a public
comment period. The public is welcome
to submit written comments in advance
of the meeting, to the contact person
below. Written comments received in
advance of the meeting will be included
in the official record of the meeting. The
public is also welcomed to listen to the
meeting by joining the audio conference
(information below). The audio
conference line has 150 ports for callers.
DATES: The meeting will be held on
September 29, 2022, from 11:00 a.m. to
3:30 p.m., EDT. Written comments must
be received on or before September 22,
2022.
ADDRESSES: You may submit comments
by mail to: Sherri Diana, National
Institute for Occupational Safety and
Health, 1090 Tusculum Avenue, MS C–
34, Cincinnati, Ohio 45226.
Meeting Information: Audio
Conference Call via FTS Conferencing.
The USA toll-free dial-in number is 1–
866–659–0537; the pass code is
9933701.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Rashaun Roberts, Ph.D., Designated
Federal Officer, NIOSH, CDC, 1090
Tusculum Avenue, Mailstop C–24,
Cincinnati, Ohio 45226, Telephone:
(513) 533–6800, Toll Free 1(800) CDC–
INFO, Email: ocas@cdc.gov.
SUPPLEMENTARY INFORMATION:
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation
Program Act of 2000 to advise the
President on a variety of policy and
technical functions required to
implement and effectively manage the
new compensation program. Key
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functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines that
have been promulgated by the
Department of Health and Human
Services (HHS) as a final rule; advice on
methods of dose reconstruction, which
have also been promulgated by HHS as
a final rule; advice on the scientific
validity and quality of dose estimation
and reconstruction efforts being
performed for purposes of the
compensation program; and advice on
petitions to add classes of workers to the
Special Exposure Cohort (SEC). In
December 2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS,
which subsequently delegated this
authority to CDC. NIOSH implements
this responsibility for CDC.
The charter was issued on August 3,
2001, renewed at appropriate intervals,
and rechartered under Executive Order
13889 on March 22, 2022, and will
terminate on March 22, 2024.
Purpose: The Advisory Board is
charged with (a) providing advice to the
Secretary, HHS, on the development of
guidelines under Executive Order
13179; (b) providing advice to the
Secretary, HHS, on the scientific
validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advise the Secretary on
whether there is a class of employees at
any Department of Energy facility who
were exposed to radiation but for whom
it is not feasible to estimate their
radiation dose, and on whether there is
reasonable likelihood that such
radiation doses may have endangered
the health of members of this class. SPR
is responsible for overseeing, tracking,
and participating in the reviews of all
procedures used in the dose
reconstruction process by the NIOSH
Division of Compensation Analysis and
Support (DCAS) and its dose
reconstruction contractor (Oak Ridge
Associated Universities—ORAU).
Matters To Be Considered: The agenda
will include discussions on the
following: a) Discussions of technical
guidance documents related to: Texas
City Chemicals, Weldon Spring Plant,
Birdsboro Steel and Foundry Company,
Grand Junction Facilities, Peek Street
Facility, dose reconstruction default
assumptions and methods, and template
dose reconstruction methodologies (b)
Preparation for December 2022 Full
ABRWH meeting, and (c) Newly Issued
Guidance Documents and Supplemental
topics. Agenda items are subject to
change as priorities dictate. For
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50337
additional information, please contact
Toll Free 1(800) 232–4636.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2022–17617 Filed 8–15–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1728]
AbbVie Inc., et al.; Withdrawal of
Approval of 30 New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 30 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
September 15, 2022.
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.
SUMMARY:
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 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:
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Federal Register / Vol. 87, No. 157 / Tuesday, August 16, 2022 / Notices
Application No.
Drug
Applicant
NDA 005856 ........
Tridione (trimethadione) Tablets, 150 milligrams (mg); Tridione
(trimethadione) Capsules, 300 mg; Tridione (trimethadione) Oral Solution, 200 mg/5 milliliters (mL).
Cantil (mepenzolate bromide) Tablets, 25 mg; Cantil (mepenzolate bromide) Solution, 25 mg/5 mL.
Dyazide (hydrochlorothiazide/triamterene) Capsules, 25 mg/37.5 mg
and 25 mg/50 mg.
Tigan (trimethobenzamide hydrochloride (HCl)) Capsules, 300 mg .......
AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL 60064.
NDA 010679 ........
NDA 016042 ........
NDA 017531 ........
NDA 017565 ........
NDA 018053 ........
Norinyl 1+ 35 (ethinyl estradiol and norethindrone) Tablets, 0.035 mg/1
mg.
NephrAmine 5.4% (amino acids) Injection, 5.4% (5.4 grams (g)/100
mL).
Bupivacaine HCl Injection, 0.25%, 0.5%, and 0.75% ..............................
NDA 019558 ........
Prinivil (lisinopril) Tablets, 2.5 mg, 5 mg, 10 mg, 20 mg, and 40 mg .....
NDA 019805 ........
NDA 019917 ........
Heparin Sodium in 5% Dextrose Injection, 4,000 Units/100 mL and
5,000 Units/100 mL.
Duragesic (fentanyl transdermal system) Extended-release Film, 12.5
micrograms (mcg)/hour, 25 mcg/hour, 37.5 mcg/hour, 50 mcg/hour,
75 mcg/hour, and 100 mcg/hour.
Morphine Sulfate Injection, 0.5 mg/mL ....................................................
NDA 020156 ........
Videx (didanosine) Powder for Oral Solution, 10 mg/mL ........................
NDA 020570 ........
Quadramet (samarium sm 153 lexidronam pentasodium) Injection, 50
millicuries/mL.
Tarka (trandolapril and verapamil HCl) Extended-release Tablets, 1
mg/240 mg, 2 mg/180 mg, 2 mg/240 mg, and 4 mg/240 mg.
Requip (ropinirole HCl) Tablets, equivalent to (EQ) 0.25 mg base, EQ
0.5 mg base, EQ 1 mg base, EQ 2 mg base, EQ 3 mg base, EQ 4
mg base, and EQ 5 mg base.
Crixivan (indinavir sulfate) Capsules, EQ 100 mg base, EQ 200 mg
base, EQ 333 mg base, and EQ 400 mg base.
Subutex (buprenorphine HCl), sublingual tablets, EQ 2mg base and
EQ 8mg base.
Suboxone (buprenorphine HCl and naloxone HCl) Sublingual Tablets,
EQ 2 mg base/EQ 0.5 mg base, and EQ 8 mg base/EQ 2 mg base.
Preven Emergency Contraceptive Kit (ethinyl estradiol and
levonorgestrel) Tablets, 0.05 mg/0.25 mg.
NDA 017766 ........
NDA 019813 ........
NDA 020591 ........
NDA 020658 ........
NDA 020685 ........
NDA 020732 ........
NDA 020733 ........
NDA 020946 ........
NDA 021183 ........
NDA 021627 ........
NDA 022008 ........
NDA 022205 ........
NDA 022246 ........
NDA 022401 ........
NDA 050662 ........
NDA 050698 ........
NDA 050775 ........
NDA 209305 ........
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NDA 211210 ........
Videx EC (didanosine) Delayed-release Capsules, 125 mg, 200 mg,
250 mg, and 400 mg.
Namenda (memantine HCl) Oral Solution, 2 mg/mL ...............................
Requip XL (ropinirole HCl) Extended-release Tablets, EQ 2 mg base,
EQ 3 mg base, EQ 4 mg base, EQ 6 mg base, EQ 8 mg base, and
EQ 12 mg base.
Giazo (balsalazide disodium) Tablets, 1.1 g ............................................
Metozolv ODT (metoclopramide HCl) Orally Disintegrating Tablets, EQ
5 mg base and EQ 10 mg base.
Twynsta (amlodipine besylate and telmisartan) Tablets, EQ 5 mg base/
40 mg, EQ 5 mg base/80 mg, EQ 10 mg base/40 mg, and EQ 10
mg base/80 mg.
Biaxin Filmtab (clarithromycin,) Tablets, 250 mg and 500 mg ................
Biaxin Granules for Oral Suspension (clarithromycin) 125 mg/5 mL,
187 mg/5 mL, and 250 mg/5 mL.
Biaxin XL Filmtab (clarithromycin) Extended-release Tablets, 500 mg ...
Eskata (hydrogen peroxide) Topical Solution, 40% .................................
Qmiiz ODT (meloxicam) Orally Disintegrating Tablets, 7.5 mg and 15
mg.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of September
15, 2022. Approval of each entire
application is withdrawn, including any
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strengths and dosage forms included in
the application but inadvertently
missing from the table. Introduction or
delivery for introduction into interstate
commerce of products without
approved new drug applications
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Sanofi-Aventis U.S., LLC, 55 Corporate Dr.,
Bridgewater, NJ 08807.
GlaxoSmithKline LLC, 5 Crescent Dr., Philadelphia, PA 19112.
King Pharmaceuticals LLC, 235 East 42nd St.,
New York, NY 10017.
Allergan Sales, LLC, 5 Giralda Farms, Madison,
NJ 07940.
B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 18109.
Hospira, Inc., 275 North Field Dr., Bldg. H1–3S,
Lake Forest, IL 60045.
Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc., 1 Merck Dr., Whitehouse
Station, NJ 08889–0100.
Hospira, Inc.
Janssen Research & Development, LLC, 1000
U.S. Route 202, Raritan, NJ 08869.
ICU Medical, Inc., 600 N. Field Dr., Lake Forest,
IL 60045.
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543–4000.
Lantheus Medical Imaging, Inc., 331 Treble Cove
Rd., Bldg. 300–2, North Billerica, MA 01862.
AbbVie Inc.
GlaxoSmithKline LLC.
Merck Sharp & Dohme Corp.
Indivior Inc., 10710 Midlothian Turnpike, Suite
125, North Chesterfield, VA 23235.
Do.
Teva Branded Pharmaceutical Products R&D,
Inc., 145 Brandywine Pkwy., West Chester, PA
19380.
Bristol-Myers Squibb Co.
Allergan Sales, LLC.
GlaxoSmithKline LLC.
Salix Pharmaceuticals, Inc., 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
Do.
Boehringer Ingelheim Pharmaceuticals, Inc., 900
Ridgebury Rd., P.O. Box 368, Ridgefield, CT
06877.
AbbVie Inc.
Do.
Do.
Aclaris Therapeutics, Inc., 640 Lee Rd., Suite
200, Wayne, PA 19087.
TerSera Therapeutics LLC, 520 Lake Cook Rd.,
Suite 500, Deerfield, IL 60015.
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 September 15, 2022
may continue to be dispensed until the
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Federal Register / Vol. 87, No. 157 / Tuesday, August 16, 2022 / Notices
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: August 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17534 Filed 8–15–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0275–30D]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before September 15,
2022.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
SUMMARY:
or (202) 264–0041. When submitting
comments or requesting information,
please include the document identifier
OS–0990–0275–30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of Collection: Performance Data
System (PDS).
Type of Collection: Extension.
OMB No.: 0990–0275.
Abstract: This request for clearance is
to extend data collection activities for a
currently approved collection using the
OMB approved Performance Data
System (PDS) (OMB No. 0990–0275),
the tool used by the Office of Minority
Health (OMH) to collect program
management and performance data for
all OMH-funded projects. The revised
data collection instrument keeps all the
same data elements, but includes
additional formatting to clarify data
elements. Additionally, a few columns
were reordered in order to make the
form more intuitive. Grantee data
collection via the UDS (original data
collection system) was first approved by
OMB on June 7, 2004 (OMB No. 0990–
275).
Need and Proposed Use of the
Information: The clearance is needed to
continue data collection using the PDS,
a system that enables OMH to comply
with Federal reporting requirements and
monitor and evaluate performance by
enabling the efficient collection of
performance-oriented data tied to OMHwide performance reporting needs. The
ability to monitor and evaluate
performance in this manner, and to
work towards continuous program
improvement are basic functions that
OMH must be able to accomplish to
carry out its mandate with the most
effective and appropriate use of
resources.
Likely Respondents: Respondents for
this data collection include the project
directors for OMH-funded projects and/
or the date entry persons for each OMHfunded project. Affected public includes
non-profit institutions, State, Local, or
Tribal Governments.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Number
responses per
respondent
Form name
Burden ..........................
OMH Grantee ..............
PDS .............................
Record Keeping ..........
100
100
4
4
20/60
25/60
133.33
166.67
Total ......................
.....................................
.....................................
100
4
45/60
300
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
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Average
burden per
response
(in hours)
Type of
respondent
[FR Doc. 2022–17564 Filed 8–15–22; 8:45 am]
BILLING CODE 4150–29–P
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Total burden
hours
]]>Agencies
[Federal Register Volume 87, Number 157 (Tuesday, August 16, 2022)]
[Notices]
[Pages 50337-50339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17534]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1728]
AbbVie Inc., et al.; Withdrawal of Approval of 30 New Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 30 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 September 15, 2022.
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 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 50338]]
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 005856................ Tridione (trimethadione) AbbVie Inc., 1
Tablets, 150 milligrams North Waukegan
(mg); Tridione Rd., North
(trimethadione) Chicago, IL
Capsules, 300 mg; 60064.
Tridione
(trimethadione) Oral
Solution, 200 mg/5
milliliters (mL).
NDA 010679................ Cantil (mepenzolate Sanofi-Aventis
bromide) Tablets, 25 U.S., LLC, 55
mg; Cantil (mepenzolate Corporate Dr.,
bromide) Solution, 25 Bridgewater, NJ
mg/5 mL. 08807.
NDA 016042................ Dyazide GlaxoSmithKline
(hydrochlorothiazide/ LLC, 5 Crescent
triamterene) Capsules, Dr.,
25 mg/37.5 mg and 25 mg/ Philadelphia, PA
50 mg. 19112.
NDA 017531................ Tigan (trimethobenzamide King
hydrochloride (HCl)) Pharmaceuticals
Capsules, 300 mg. LLC, 235 East
42nd St., New
York, NY 10017.
NDA 017565................ Norinyl 1+ 35 (ethinyl Allergan Sales,
estradiol and LLC, 5 Giralda
norethindrone) Tablets, Farms, Madison,
0.035 mg/1 mg. NJ 07940.
NDA 017766................ NephrAmine 5.4% (amino B. Braun Medical
acids) Injection, 5.4% Inc., 901 Marcon
(5.4 grams (g)/100 mL). Blvd., Allentown,
PA 18109.
NDA 018053................ Bupivacaine HCl Hospira, Inc., 275
Injection, 0.25%, 0.5%, North Field Dr.,
and 0.75%. Bldg. H1-3S, Lake
Forest, IL 60045.
NDA 019558................ Prinivil (lisinopril) Merck Sharp &
Tablets, 2.5 mg, 5 mg, Dohme Corp., a
10 mg, 20 mg, and 40 mg. subsidiary of
Merck & Co.,
Inc., 1 Merck
Dr., Whitehouse
Station, NJ 08889-
0100.
NDA 019805................ Heparin Sodium in 5% Hospira, Inc.
Dextrose Injection,
4,000 Units/100 mL and
5,000 Units/100 mL.
NDA 019813................ Duragesic (fentanyl Janssen Research &
transdermal system) Development, LLC,
Extended-release Film, 1000 U.S. Route
12.5 micrograms (mcg)/ 202, Raritan, NJ
hour, 25 mcg/hour, 37.5 08869.
mcg/hour, 50 mcg/hour,
75 mcg/hour, and 100
mcg/hour.
NDA 019917................ Morphine Sulfate ICU Medical, Inc.,
Injection, 0.5 mg/mL. 600 N. Field Dr.,
Lake Forest, IL
60045.
NDA 020156................ Videx (didanosine) Bristol-Myers
Powder for Oral Squibb Co., P.O.
Solution, 10 mg/mL. Box 4000,
Princeton, NJ
08543-4000.
NDA 020570................ Quadramet (samarium sm Lantheus Medical
153 lexidronam Imaging, Inc.,
pentasodium) Injection, 331 Treble Cove
50 millicuries/mL. Rd., Bldg. 300-2,
North Billerica,
MA 01862.
NDA 020591................ Tarka (trandolapril and AbbVie Inc.
verapamil HCl) Extended-
release Tablets, 1 mg/
240 mg, 2 mg/180 mg, 2
mg/240 mg, and 4 mg/240
mg.
NDA 020658................ Requip (ropinirole HCl) GlaxoSmithKline
Tablets, equivalent to LLC.
(EQ) 0.25 mg base, EQ
0.5 mg base, EQ 1 mg
base, EQ 2 mg base, EQ
3 mg base, EQ 4 mg
base, and EQ 5 mg base.
NDA 020685................ Crixivan (indinavir Merck Sharp &
sulfate) Capsules, EQ Dohme Corp.
100 mg base, EQ 200 mg
base, EQ 333 mg base,
and EQ 400 mg base.
NDA 020732................ Subutex (buprenorphine Indivior Inc.,
HCl), sublingual 10710 Midlothian
tablets, EQ 2mg base Turnpike, Suite
and EQ 8mg base. 125, North
Chesterfield, VA
23235.
NDA 020733................ Suboxone (buprenorphine Do.
HCl and naloxone HCl)
Sublingual Tablets, EQ
2 mg base/EQ 0.5 mg
base, and EQ 8 mg base/
EQ 2 mg base.
NDA 020946................ Preven Emergency Teva Branded
Contraceptive Kit Pharmaceutical
(ethinyl estradiol and Products R&D,
levonorgestrel) Inc., 145
Tablets, 0.05 mg/0.25 Brandywine Pkwy.,
mg. West Chester, PA
19380.
NDA 021183................ Videx EC (didanosine) Bristol-Myers
Delayed-release Squibb Co.
Capsules, 125 mg, 200
mg, 250 mg, and 400 mg.
NDA 021627................ Namenda (memantine HCl) Allergan Sales,
Oral Solution, 2 mg/mL. LLC.
NDA 022008................ Requip XL (ropinirole GlaxoSmithKline
HCl) Extended-release LLC.
Tablets, EQ 2 mg base,
EQ 3 mg base, EQ 4 mg
base, EQ 6 mg base, EQ
8 mg base, and EQ 12 mg
base.
NDA 022205................ Giazo (balsalazide Salix
disodium) Tablets, 1.1 Pharmaceuticals,
g. Inc., 400
Somerset
Corporate Blvd.,
Bridgewater, NJ
08807.
NDA 022246................ Metozolv ODT Do.
(metoclopramide HCl)
Orally Disintegrating
Tablets, EQ 5 mg base
and EQ 10 mg base.
NDA 022401................ Twynsta (amlodipine Boehringer
besylate and Ingelheim
telmisartan) Tablets, Pharmaceuticals,
EQ 5 mg base/40 mg, EQ Inc., 900
5 mg base/80 mg, EQ 10 Ridgebury Rd.,
mg base/40 mg, and EQ P.O. Box 368,
10 mg base/80 mg. Ridgefield, CT
06877.
NDA 050662................ Biaxin Filmtab AbbVie Inc.
(clarithromycin,)
Tablets, 250 mg and 500
mg.
NDA 050698................ Biaxin Granules for Oral Do.
Suspension
(clarithromycin) 125 mg/
5 mL, 187 mg/5 mL, and
250 mg/5 mL.
NDA 050775................ Biaxin XL Filmtab Do.
(clarithromycin)
Extended-release
Tablets, 500 mg.
NDA 209305................ Eskata (hydrogen Aclaris
peroxide) Topical Therapeutics,
Solution, 40%. Inc., 640 Lee
Rd., Suite 200,
Wayne, PA 19087.
NDA 211210................ Qmiiz ODT (meloxicam) TerSera
Orally Disintegrating Therapeutics LLC,
Tablets, 7.5 mg and 15 520 Lake Cook
mg. Rd., Suite 500,
Deerfield, IL
60015.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
September 15, 2022. Approval of each entire application is withdrawn,
including any strengths and dosage forms included in the application
but 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 September 15, 2022 may
continue to be dispensed until the
[[Page 50339]]
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.
Dated: August 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17534 Filed 8-15-22; 8:45 am]
BILLING CODE 4164-01-P
