Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 12 New Drug Applications, 3877-3878 [2025-00743]
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Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices
3877
TABLE 1—ANDAS FOR WHICH APPROVAL IS WITHDRAWN—Continued
Application No.
Drug
Applicant
ANDA 207919 ....
Acyclovir Sodium injectable, EQ 50 mg base/mL ...................
ANDA 209325 ....
Miglustat capsule, 100 mg .......................................................
ANDA 209708 ....
ANDA 214428 ....
Mivacurium Chloride solution, EQ 10 mg base/5 mL (EQ 2
mg base/mL) and EQ 20 mg base/10 mL (EQ 2 mg base/
mL).
Ranitidine HCl capsule, EQ 150 mg base and EQ 300 mg
base.
Niacin extended-release tablet, 500 mg and 1 g ....................
Dr. Reddy’s Laboratories Inc., 107 College Rd. East, Princeton, NJ 08540.
Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite
201, Berlin, CT 06037.
Woodward Pharma Services, LLC, 47220 Cartier Dr., Suite
A, Wixom, MI 48393.
ANDA 215908 ....
Nitisinone capsule, 2 mg, 5 mg, 10 mg, and 20 mg ...............
ANDA 217094 ....
Fluphenazine HCl tablet, 1 mg, 2.5 mg, 5 mg, and 10 mg .....
ANDA 211893 ....
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of February 14,
2025. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from table 1.
Introduction or delivery for introduction
into interstate commerce of products
listed in table 1 without an approved
new drug application or ANDA violates
sections 505(a) and 301(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)). Drug products that
are listed in table 1 that are in inventory
on February 14, 2025 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.
Appco Pharma LLC, 262 Old New Brunswick Rd., Suite M,
N, B–1, F, Piscataway, NJ 08854.
Sciecure Pharma Inc., U.S. Agent for Beijing Sciecure Pharmaceutical Co., Ltd., 138 Glendale Ave., Edison, NJ
08817.
Torrent Pharma Inc., 106 Allen Rd., Suite 305, Basking
Ridge, NJ 07920.
Torrent Pharma Inc., U.S. Agent for Torrent Pharmaceuticals
Ltd., 106 Allen Rd., Suite 305, Basking Ridge, NJ 07920.
Dated: January 8, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025–00742 Filed 1–14–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–5851]
Teva Branded Pharmaceutical
Products R&D, Inc., et al.; Withdrawal
of Approval of 12 New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 12 new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
SUMMARY:
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
February 14, 2025.
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 table 1 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:
TABLE 1—NDAS FOR WHICH APPROVAL IS WITHDRAWN
Application No.
NDA 009388 ..........
NDA 012836 ..........
NDA 018817 ..........
NDA 021743 ..........
lotter on DSK11XQN23PROD with NOTICES1
NDA 021785 ..........
NDA 021937 ..........
NDA 022383 ..........
NDA 204412 ..........
NDA 210875 ..........
VerDate Sep<11>2014
Drug
Applicant
Diamox IV (acetazolamide) Injectable, Equivalent to (EQ)
500 milligrams (mg) base per vial.
Persantine (dipyridamole) Tablets, 25mg, 50mg, and 75mg
Calan (verapamil hydrochloride (HCl)) Tablets, 40 mg, 80
mg, 120 mg, and 160 mg.
Tarceva (erlotinib HCl) Tablets, EQ 25 mg base, EQ 100
mg base, and EQ 150 mg base.
Invirase (saquinavir mesylate) Tablets, EQ 500 mg base .....
Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate) Tablets, 600 mg/200 mg/300 mg.
Arcapta Neohaler (indacaterol maleate) Powder for Inhalation, EQ 75 micrograms base.
Delzicol (mesalamine), Delayed-Release Capsules, 400 mg
Kynmobi (apomorphine HCl) Sublingual Film, 10 mg, 15
mg, 20 mg, 25 mg, and 30 mg.
18:37 Jan 14, 2025
Jkt 265001
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
Teva Branded Pharmaceutical Products R&D, Inc., 145
Brandywine Parkway, West Chester, PA 19380.
Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury
Road, P.O. Box 368, Ridgefield, CT 06877.
Pfizer Inc., 66 Hudson Boulevard East, New York, NY
10001.
OSI Pharmaceuticals, LLC, 2375 Waterview Dr., Northbrook, IL 60062.
Hoffmann-La Roche, Inc. c/o Genentech, Inc., 1 DNA Way,
South San Francisco, CA 94080.
Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA
94404.
Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936.
AbbVie Inc., 1 N. Waukegan Rd., North Chicago, IL 60064.
Sumitomo Pharma America, Inc., 84 Waterford Dr., Marlborough, MA 01752.
E:\FR\FM\15JAN1.SGM
15JAN1
3878
Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices
TABLE 1—NDAS FOR WHICH APPROVAL IS WITHDRAWN—Continued
Application No.
Drug
NDA 211172 ..........
NDA 212640 ..........
Tegsedi (inotersen sodium) Solution for Injection, EQ 284
mg base/1.5 mL.
Exservan (riluzole) Oral Film, 50 mg .....................................
NDA 213426 ..........
Seglentis (celecoxib and tramadol HCl) 56 mg; 44 mg .........
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of February 14,
2025. Approval of each entire
application is withdrawn, including any
strengths and dosage forms included in
the application but inadvertently
missing from table 1. Introduction or
delivery for introduction into interstate
commerce of products listed in table 1
without an approved NDA violates
sections 505(a) and 301(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)). Drug products that
are listed in table 1 that are in inventory
on February 14, 2025 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 6, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025–00743 Filed 1–14–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–5716]
High-Protein Yogurt; Request for
Information
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for information.
The Food and Drug
Administration (FDA or we) is
requesting information and data about
the manufacturing processes and
ingredients used to make certain dairy
products referred to as high-protein
yogurt, Greek yogurt, or Greek-style
yogurt in this document. We are taking
this action, in part, because the yogurt
standard of identity may not align with
certain manufacturing processes and
ingredients used to concentrate protein
to manufacture these products. We
intend to use the information and data
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:37 Jan 14, 2025
Jkt 265001
Applicant
Akcea Therapeutics, Inc., 2850 Gazelle Ct., Carlsbad, CA
92010.
Aquestive Therapeutics, 30 Technology Dr., Warren, NJ
07059.
Kowa Pharmaceuticals America, Inc., 530 Industrial Park
Blvd., Montgomery, AL 36117.
to help determine what type(s) of
actions, if any, should be taken.
DATES: Either electronic or written
comments on the notice must be
submitted by April 15, 2025.
ADDRESSES: You may submit comments
and information as follows. Please note
that late, untimely filed comments will
not be considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
April 15, 2025. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received 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’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
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–
2024–N–5716 for ‘‘High-Protein Yogurt;
Request for Information.’’ 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, 240–402–7500.
• 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.’’ We
will review this copy, including the
claimed confidential information, in our
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
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
E:\FR\FM\15JAN1.SGM
15JAN1
]]>Agencies
[Federal Register Volume 90, Number 9 (Wednesday, January 15, 2025)]
[Notices]
[Pages 3877-3878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00743]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5851]
Teva Branded Pharmaceutical Products R&D, Inc., et al.;
Withdrawal of Approval of 12 New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 12 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 February 14, 2025.
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 table 1 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.
Table 1--NDAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 009388.............. Diamox IV Teva Branded
(acetazolamide) Pharmaceutical
Injectable, Products R&D, Inc.,
Equivalent to (EQ) 145 Brandywine
500 milligrams (mg) Parkway, West
base per vial. Chester, PA 19380.
NDA 012836.............. Persantine Boehringer Ingelheim
(dipyridamole) Pharmaceuticals,
Tablets, 25mg, 50mg, Inc., 900 Ridgebury
and 75mg. Road, P.O. Box 368,
Ridgefield, CT 06877.
NDA 018817.............. Calan (verapamil Pfizer Inc., 66 Hudson
hydrochloride (HCl)) Boulevard East, New
Tablets, 40 mg, 80 York, NY 10001.
mg, 120 mg, and 160
mg.
NDA 021743.............. Tarceva (erlotinib OSI Pharmaceuticals,
HCl) Tablets, EQ 25 LLC, 2375 Waterview
mg base, EQ 100 mg Dr., Northbrook, IL
base, and EQ 150 mg 60062.
base.
NDA 021785.............. Invirase (saquinavir Hoffmann-La Roche,
mesylate) Tablets, EQ Inc. c/o Genentech,
500 mg base. Inc., 1 DNA Way,
South San Francisco,
CA 94080.
NDA 021937.............. Atripla (efavirenz, Gilead Sciences, Inc.,
emtricitabine, and 333 Lakeside Dr.,
tenofovir disoproxil Foster City, CA
fumarate) Tablets, 94404.
600 mg/200 mg/300 mg.
NDA 022383.............. Arcapta Neohaler Novartis
(indacaterol maleate) Pharmaceuticals
Powder for Corp., 1 Health
Inhalation, EQ 75 Plaza, East Hanover,
micrograms base. NJ 07936.
NDA 204412.............. Delzicol (mesalamine), AbbVie Inc., 1 N.
Delayed-Release Waukegan Rd., North
Capsules, 400 mg. Chicago, IL 60064.
NDA 210875.............. Kynmobi (apomorphine Sumitomo Pharma
HCl) Sublingual Film, America, Inc., 84
10 mg, 15 mg, 20 mg, Waterford Dr.,
25 mg, and 30 mg. Marlborough, MA
01752.
[[Page 3878]]
NDA 211172.............. Tegsedi (inotersen Akcea Therapeutics,
sodium) Solution for Inc., 2850 Gazelle
Injection, EQ 284 mg Ct., Carlsbad, CA
base/1.5 mL. 92010.
NDA 212640.............. Exservan (riluzole) Aquestive
Oral Film, 50 mg. Therapeutics, 30
Technology Dr.,
Warren, NJ 07059.
NDA 213426.............. Seglentis (celecoxib Kowa Pharmaceuticals
and tramadol HCl) 56 America, Inc., 530
mg; 44 mg. Industrial Park
Blvd., Montgomery, AL
36117.
------------------------------------------------------------------------
Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of February
14, 2025. Approval of each entire application is withdrawn, including
any strengths and dosage forms included in the application but
inadvertently missing from table 1. Introduction or delivery for
introduction into interstate commerce of products listed in table 1
without an approved NDA violates sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).
Drug products that are listed in table 1 that are in inventory on
February 14, 2025 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 6, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-00743 Filed 1-14-25; 8:45 am]
BILLING CODE 4164-01-P
