Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications, 28950-28951 [2020-10367]
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Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
the structure (including increasing
transparency) and resources to ensure
customer experience is a focal point for
agency leadership. To support this,
OMB Circular A–11 Section 280
established government-wide standards
for mature customer experience
organizations in government and
measurement. To enable Federal
programs to deliver the experience
taxpayers deserve, they must undertake
three general categories of activities:
Conduct ongoing customer research,
gather and share customer feedback, and
test services and digital products.
These data collection efforts may be
either qualitative or quantitative in
nature or may consist of mixed
methods. Additionally, data may be
collected via a variety of means,
including but not limited to electronic
or social media, direct or indirect
observation (i.e., in person, video and
audio collections), interviews,
questionnaires, surveys, and focus
groups. The Centers for Medicare and
Medicaid Services (CMS) will limit its
inquiries to data collections that solicit
strictly voluntary opinions or responses.
Steps will be taken to ensure anonymity
of respondents in each activity covered
by this request.
The results of the data collected will
be used to improve the delivery of
Federal services and programs. It will
include the creation of personas,
customer journey maps, and reports and
summaries of customer feedback data
and user insights. It will also provide
government-wide data on customer
experience that can be displayed on
performance.gov to help build
transparency and accountability of
Federal programs to the customers they
serve.
Dated: May 8, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–10282 Filed 5–13–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 16 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applications be withdrawn.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:
Approval is withdrawn as of
June 15, 2020.
DATES:
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.
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:
Food and Drug Administration
[Docket No. FDA–2020–N–1117]
Janssen Pharmaceuticals, Inc., et al.;
Withdrawal of Approval of 16 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Application No.
Drug
Applicant
NDA 011529 ..........
NDA 019579 ..........
Parafon Forte DSC (chlorzoxazone), Caplets, 500 milligrams (mg).
Ritalin-SR (methylphenidate hydrochloride (HCl)) ExtendedRelease Tablets, 20 mg.
Depakene (valproic acid) Oral Solution, 250 mg/5 milliliter
(mL).
Terazol 7 (terconazole) Vaginal Cream, 0.4% .......................
NDA 020119 ..........
Vumon (teniposide) Injection, 10 mg/mL ...............................
NDA 020388 ..........
NDA 020741 ..........
Navelbine (vinorelbine tartrate) Injection, Equivalent to (EQ)
10 mg/mL base.
Prandin (repaglinide) Tablets, 0.5 mg, 1.0 mg, and 2.0 mg ..
NDA 020920 ..........
Natrecor (nesiritide) Injection, 1.5 mg/vial .............................
NDA 021001 ..........
Axert (almotriptan malate) Tablets, EQ 6.25 mg base and
EQ 12.5 mg base.
Tricor (fenofibrate) Tablets, 54 mg and 160 mg ....................
Striant (testosterone buccal system) Extended-Release Tablets, 30 mg.
Children’s ElixSure IB (ibuprofen) Oral Suspension, 100mg/
5 mL.
Janssen Pharmaceuticals, Inc., 1000 Route 202 South, P.O.
Box 300, Raritan, NJ 08869.
Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936.
AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL
60064.
Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton
Rd., Titusville, NJ 08560.
HQ Specialty Pharma, 120 Route 17 North, Paramus, NJ
07652.
Pierre Fabre Medicament c/o Pierre Fabre Pharmaceuticals,
Inc., 8 Campus Dr., Suite 202, Parsippany, NJ 07054.
Gemini Laboratories, LLC, 400 Crossing Blvd., 5th Floor,
Bridgewater, NJ 08807.
Scios, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ
08560.
Janssen Pharmaceuticals, Inc.
NDA 018029 ..........
NDA 018082 ..........
jbell on DSKJLSW7X2PROD with NOTICES
CMS will collect this information by
electronic means when possible, as well
as by mail, fax, telephone, technical
discussions, and in-person interviews.
CMS may also utilize observational
techniques to collect this information.
Form Number: CMS–10710 (OMB
control number: 0938-New); Frequency:
Occasionally; Affected Public:
Individuals or Households; Private
Sector (business or other for-profits, notfor-profit institutions), State, Local or
Tribal governments; Federal
government; and Universities; Number
of Respondents: 1,001,750; Number of
Responses: Varied, dependent upon the
data collection method used. The
possible response time to complete a
questionnaire or survey may be 3
minutes or up to 2 hours to participate
in an interview.; Total Annual Hours:
51,175. (For questions regarding this
collection contact Aaron Lartey at 410–
786–7866).
NDA 021203 ..........
NDA 021543 ..........
NDA 021604 ..........
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AbbVie Inc.
Auxilium Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern,
PA 19355.
Moberg Pharma North America LLC, 7 East Frederick
Place, Suite 100, Cedar Knolls, NJ 07927.
E:\FR\FM\14MYN1.SGM
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Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
Application No.
Drug
Applicant
NDA 021611 ..........
Opana (oxymorphone HCl) Tablets, 5mg and 10mg .............
NDA 022321 ..........
Embeda (morphine sulfate and naltrexone HCl) ExtendedRelease Capsules, 20 mg/0.8 mg, 30 mg/1.2 mg, 50 mg/
2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, and 100 mg/4 mg.
Abstral (fentanyl) Sublingual Tablets,100 micrograms (mcg),
200 mcg, 300 mcg, 400 mcg, 600 mcg, and 800 mcg.
Monodox (doxycycline monohydrate) Capsules, EQ 50mg
base, EQ 75mg base, and EQ 100mg base.
Endo Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern, PA
19355.
Alpharma Pharmaceuticals, LLC, 235 East 42nd St., New
York, NY 10017.
NDA 022510 ..........
NDA 050641 ..........
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of June 15, 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 June 15, 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: May 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10367 Filed 5–13–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0501]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Third Party
Disclosure and Recordkeeping
Requirements for Reportable Food
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
28951
VerDate Sep<11>2014
18:29 May 13, 2020
Jkt 250001
Sentynl Therapeutics, Inc., 420 Stevens Ave., Suite 200,
Solana Beach, CA 92075.
Aqua Pharmaceuticals, LLC, 707 Eagleview Blvd., Suite
200, Exton, PA 19341.
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of FDA’s thirdparty disclosure and recordkeeping
requirements for reportable food.
DATES: Submit either electronic or
written comments on the collection of
information by July 13, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 13, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 13, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2009–N–0501 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Third
Party Disclosure and Recordkeeping
Requirements for Reportable Food.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
E:\FR\FM\14MYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28950-28951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10367]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1117]
Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of
16 New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 16 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 June 15, 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.
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.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 011529............... Parafon Forte DSC Janssen
(chlorzoxazone), Pharmaceuticals,
Caplets, 500 Inc., 1000 Route 202
milligrams (mg). South, P.O. Box 300,
Raritan, NJ 08869.
NDA 018029............... Ritalin-SR Novartis
(methylphenidate Pharmaceuticals
hydrochloride (HCl)) Corp., 1 Health
Extended-Release Plaza, East Hanover,
Tablets, 20 mg. NJ 07936.
NDA 018082............... Depakene (valproic AbbVie Inc., 1 North
acid) Oral Solution, Waukegan Rd., North
250 mg/5 milliliter Chicago, IL 60064.
(mL).
NDA 019579............... Terazol 7 Janssen
(terconazole) Vaginal Pharmaceuticals,
Cream, 0.4%. Inc., 1125 Trenton-
Harbourton Rd.,
Titusville, NJ
08560.
NDA 020119............... Vumon (teniposide) HQ Specialty Pharma,
Injection, 10 mg/mL. 120 Route 17 North,
Paramus, NJ 07652.
NDA 020388............... Navelbine (vinorelbine Pierre Fabre
tartrate) Injection, Medicament c/o
Equivalent to (EQ) 10 Pierre Fabre
mg/mL base. Pharmaceuticals,
Inc., 8 Campus Dr.,
Suite 202,
Parsippany, NJ
07054.
NDA 020741............... Prandin (repaglinide) Gemini Laboratories,
Tablets, 0.5 mg, 1.0 LLC, 400 Crossing
mg, and 2.0 mg. Blvd., 5th Floor,
Bridgewater, NJ
08807.
NDA 020920............... Natrecor (nesiritide) Scios, LLC, 1125
Injection, 1.5 mg/ Trenton-Harbourton
vial. Rd., Titusville, NJ
08560.
NDA 021001............... Axert (almotriptan Janssen
malate) Tablets, EQ Pharmaceuticals,
6.25 mg base and EQ Inc.
12.5 mg base.
NDA 021203............... Tricor (fenofibrate) AbbVie Inc.
Tablets, 54 mg and
160 mg.
NDA 021543............... Striant (testosterone Auxilium
buccal system) Pharmaceuticals,
Extended-Release Inc., 1400 Atwater
Tablets, 30 mg. Dr., Malvern, PA
19355.
NDA 021604............... Children's ElixSure IB Moberg Pharma North
(ibuprofen) Oral America LLC, 7 East
Suspension, 100mg/5 Frederick Place,
mL. Suite 100, Cedar
Knolls, NJ 07927.
[[Page 28951]]
NDA 021611............... Opana (oxymorphone Endo Pharmaceuticals,
HCl) Tablets, 5mg and Inc., 1400 Atwater
10mg. Dr., Malvern, PA
19355.
NDA 022321............... Embeda (morphine Alpharma
sulfate and Pharmaceuticals,
naltrexone HCl) LLC, 235 East 42nd
Extended-Release St., New York, NY
Capsules, 20 mg/0.8 10017.
mg, 30 mg/1.2 mg, 50
mg/2 mg, 60 mg/2.4
mg, 80 mg/3.2 mg, and
100 mg/4 mg.
NDA 022510............... Abstral (fentanyl) Sentynl Therapeutics,
Sublingual Inc., 420 Stevens
Tablets,100 Ave., Suite 200,
micrograms (mcg), 200 Solana Beach, CA
mcg, 300 mcg, 400 92075.
mcg, 600 mcg, and 800
mcg.
NDA 050641............... Monodox (doxycycline Aqua Pharmaceuticals,
monohydrate) LLC, 707 Eagleview
Capsules, EQ 50mg Blvd., Suite 200,
base, EQ 75mg base, Exton, PA 19341.
and EQ 100mg base.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of June
15, 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 June 15, 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: May 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10367 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P
