Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications, 3876-3877 [2025-00742]
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Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices
Papaver 1036. 2014.
9. Montgomery, M.T., X.A. Conlan, A.G.
Theakstone, et al. ‘‘Extraction and
Determination of Morphine Present on
the Surface of Australian Food Grade
Poppy Seeds Using Acidic Potassium
Permanganate Chemiluminescence
Detection.’’ Food Analytical Methods,
13(5):1159–1165, 2020. Available at
https://doi.org/10.1007/s12161-02001729-z (accessed December 8, 2024).
10. Lo, D. and T. Chua. ‘‘Poppy Seeds:
Implications of Consumption.’’
Medicine, Science and the Law,
32(4):296–302, 1992. Available at https://
doi.org/10.1177/002580249203200403
(accessed December 8, 2024).
11. Sproll, C., R.C. Perz, R. Buschmann, et al.
‘‘Guidelines for Reduction of Morphine
in Poppy Seed Intended for Food
Purposes.’’ European Food Research and
Technology, 226(1):307–310, 2007.
Available at https://doi.org/10.1007/
s00217-006-0522-7 (accessed December.
8, 2024).
12. Shetge, S.A., M.P. Dzakovich, J.L.
Cooperstone, et al. ‘‘Concentrations of
the Opium Alkaloids Morphine,
Codeine, and Thebaine in Poppy Seeds
are Reduced After Thermal and Washing
Treatments But Are Not Affected When
Incorporated in a Model Baked Product.’’
Journal of Agricultural and Food
Chemistry, 68(18):5241–5248, 2020.
Available at https://doi.org/10.1021/
acs.jafc.0c01681 (accessed December 8,
2024).
Dated: January 8, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025–00757 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–5964]
Teva Pharmaceuticals USA, Inc., et al.;
Withdrawal of Approval of 23
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 23 abbreviated
SUMMARY:
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applications be withdrawn.
DATES: Approval is withdrawn as of
February 14, 2025.
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, 301–
796–3471, Martha.Nguyen@fda.hhs.gov.
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
§ 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.
TABLE 1—ANDAS FOR WHICH APPROVAL IS WITHDRAWN
Application No.
Drug
Applicant
ANDA 040454 ....
Promethazine Hydrochloride (HCl) injectable, 25 milligrams
(mg)/milliliters (mL) and 50 mg/mL.
Promethazine HCl injectable, 25 mg/mL and 50 mg/mL .........
Nystatin suspension, 100,000 units/mL ...................................
Teva Pharmaceuticals USA, Inc., 400 Interpace Parkway,
Bldg. A, Parsippany, NJ 07054.
Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540.
PAI Holdings, LLC, dba Pharmaceutical Associates, Inc., and
dba PAI Pharma, 1700 Perimeter Rd., Greenville, SC
29605.
Hikma Pharmaceuticals USA Inc., 2 Esterbrook Lane, Cherry
Hill, NJ 08003.
Strides Pharma Inc., U.S. Agent for Strides Pharma Global
Pte Ltd., 2 Tower Center Blvd., Suite 1102, East Brunswick, NJ 08816.
Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace
Parkway, Bldg. A, Parsippany, NJ 07054.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
ANDA 040593 ....
ANDA 064042 ....
ANDA 074811 ....
ANDA 076061 ....
ANDA 079075 ....
Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base,
EQ 0.4 mg base, EQ 0.6 mg base, and EQ 0.8 mg base.
ANDA 079240 ....
Sumatriptan Succinate injectable, EQ 6 mg base/0.5 mL (EQ
12 mg base/mL) and EQ 4 mg base/0.5 mL (EQ 8 mg
base/mL).
Promethazine HCl injectable, 25 mg/mL .................................
ANDA 084591 ....
lotter on DSK11XQN23PROD with NOTICES1
Haloperidol Decanoate injectable, Equivalent to (EQ) 50 mg
base/mL.
Pergolide Mesylate tablet, EQ 0.05 mg base, EQ 0.25 mg
base, and EQ 1 mg base.
ANDA 090016 ....
Irinotecan HCl injectable, 40 mg/2mL (20 mg/mL) and 100
mg/5 mL (20 mg/mL).
ANDA 200536 ....
Ranitidine HCl tablet, EQ 150 mg base ..................................
ANDA 201745 ....
ANDA 204991 ....
Ranitidine HCl tablet, EQ 75 mg base ....................................
Atorvastatin Calcium tablet, EQ 10 mg base, EQ 20 mg
base, EQ 40 mg base, and EQ 80 mg base.
ANDA 205512 ....
Ranitidine HCl tablet, EQ 150 mg base and EQ 300 mg base
ANDA 206155 ....
Olanzapine tablet, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and
20 mg.
ANDA 206204 ....
Piperacillin and Tazobactam injectable, EQ 12 grams (g)
base/vial; EQ 1.5 g base/vial.
Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base,
EQ 0.3 mg base, EQ 0.4 mg base, EQ 0.6 mg base, and
EQ 0.8 mg base.
ANDA 207338 ....
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18:37 Jan 14, 2025
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Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.).
Hisun Pharmaceuticals USA Inc., U.S. Agent for Hisun Pharmaceutical (Hangzhou) Co., Ltd., 200 Crossing Blvd., 2nd
Floor, Bridgewater, NJ 08807.
Strides Pharma Inc., U.S. Agent for Strides Pharma Global
Pte Ltd.
Do.
Lupin Pharmaceuticals, Inc., U.S. Agent for Lupin Ltd.,
Harborplace Tower, 111 South Calvert St., 21st Floor, Baltimore, MD 21202.
Strides Pharma Inc., U.S. Agent for Strides Pharma Global
Pte Ltd.
RegCon Solutions, LLC, U.S. Agent for Indoco Remedies
Ltd., 9920 Pacific Heights Blvd., Suite 250, San Diego, CA
92121.
Fresenius Kabi USA, LLC.
Actavis Laboratories FL, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA Inc.), 400 Interpace
Parkway, Bldg. A, Parsippany, NJ 07054.
E:\FR\FM\15JAN1.SGM
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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.
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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
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]]>Agencies
[Federal Register Volume 90, Number 9 (Wednesday, January 15, 2025)]
[Notices]
[Pages 3876-3877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00742]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5964]
Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of
23 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 23 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 February 14, 2025.
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, 301-
796-3471, [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--ANDAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 040454............ Promethazine Teva Pharmaceuticals
Hydrochloride (HCl) USA, Inc., 400
injectable, 25 Interpace Parkway,
milligrams (mg)/ Bldg. A, Parsippany,
milliliters (mL) and NJ 07054.
50 mg/mL.
ANDA 040593............ Promethazine HCl Sandoz Inc., 100
injectable, 25 mg/mL College Rd. West,
and 50 mg/mL. Princeton, NJ 08540.
ANDA 064042............ Nystatin suspension, PAI Holdings, LLC, dba
100,000 units/mL. Pharmaceutical
Associates, Inc., and
dba PAI Pharma, 1700
Perimeter Rd.,
Greenville, SC 29605.
ANDA 074811............ Haloperidol Decanoate Hikma Pharmaceuticals
injectable, Equivalent USA Inc., 2
to (EQ) 50 mg base/mL. Esterbrook Lane,
Cherry Hill, NJ
08003.
ANDA 076061............ Pergolide Mesylate Strides Pharma Inc.,
tablet, EQ 0.05 mg U.S. Agent for
base, EQ 0.25 mg base, Strides Pharma Global
and EQ 1 mg base. Pte Ltd., 2 Tower
Center Blvd., Suite
1102, East Brunswick,
NJ 08816.
ANDA 079075............ Fentanyl Citrate Watson Laboratories,
tablet, EQ 0.1 mg Inc. (an indirect,
base, EQ 0.2 mg base, wholly owned
EQ 0.4 mg base, EQ 0.6 subsidiary of Teva
mg base, and EQ 0.8 mg Pharmaceuticals USA,
base. Inc.), 400 Interpace
Parkway, Bldg. A,
Parsippany, NJ 07054.
ANDA 079240............ Sumatriptan Succinate Fresenius Kabi USA,
injectable, EQ 6 mg LLC, Three Corporate
base/0.5 mL (EQ 12 mg Dr., Lake Zurich, IL
base/mL) and EQ 4 mg 60047.
base/0.5 mL (EQ 8 mg
base/mL).
ANDA 084591............ Promethazine HCl Watson Laboratories,
injectable, 25 mg/mL. Inc. (an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals USA,
Inc.).
ANDA 090016............ Irinotecan HCl Hisun Pharmaceuticals
injectable, 40 mg/2mL USA Inc., U.S. Agent
(20 mg/mL) and 100 mg/ for Hisun
5 mL (20 mg/mL). Pharmaceutical
(Hangzhou) Co., Ltd.,
200 Crossing Blvd.,
2nd Floor,
Bridgewater, NJ
08807.
ANDA 200536............ Ranitidine HCl tablet, Strides Pharma Inc.,
EQ 150 mg base. U.S. Agent for
Strides Pharma Global
Pte Ltd.
ANDA 201745............ Ranitidine HCl tablet, Do.
EQ 75 mg base.
ANDA 204991............ Atorvastatin Calcium Lupin Pharmaceuticals,
tablet, EQ 10 mg base, Inc., U.S. Agent for
EQ 20 mg base, EQ 40 Lupin Ltd.,
mg base, and EQ 80 mg Harborplace Tower,
base. 111 South Calvert
St., 21st Floor,
Baltimore, MD 21202.
ANDA 205512............ Ranitidine HCl tablet, Strides Pharma Inc.,
EQ 150 mg base and EQ U.S. Agent for
300 mg base. Strides Pharma Global
Pte Ltd.
ANDA 206155............ Olanzapine tablet, 2.5 RegCon Solutions, LLC,
mg, 5 mg, 7.5 mg, 10 U.S. Agent for Indoco
mg, 15 mg, and 20 mg. Remedies Ltd., 9920
Pacific Heights
Blvd., Suite 250, San
Diego, CA 92121.
ANDA 206204............ Piperacillin and Fresenius Kabi USA,
Tazobactam injectable, LLC.
EQ 12 grams (g) base/
vial; EQ 1.5 g base/
vial.
ANDA 207338............ Fentanyl Citrate Actavis Laboratories
tablet, EQ 0.1 mg FL, Inc. (an
base, EQ 0.2 mg base, indirect, wholly
EQ 0.3 mg base, EQ 0.4 owned subsidiary of
mg base, EQ 0.6 mg Teva Pharmaceuticals
base, and EQ 0.8 mg USA Inc.), 400
base. Interpace Parkway,
Bldg. A, Parsippany,
NJ 07054.
[[Page 3877]]
ANDA 207919............ Acyclovir Sodium Dr. Reddy's
injectable, EQ 50 mg Laboratories Inc.,
base/mL. 107 College Rd. East,
Princeton, NJ 08540.
ANDA 209325............ Miglustat capsule, 100 Breckenridge
mg. Pharmaceutical, Inc.,
15 Massirio Dr.,
Suite 201, Berlin, CT
06037.
ANDA 209708............ Mivacurium Chloride Woodward Pharma
solution, EQ 10 mg Services, LLC, 47220
base/5 mL (EQ 2 mg Cartier Dr., Suite A,
base/mL) and EQ 20 mg Wixom, MI 48393.
base/10 mL (EQ 2 mg
base/mL).
ANDA 211893............ Ranitidine HCl capsule, Appco Pharma LLC, 262
EQ 150 mg base and EQ Old New Brunswick
300 mg base. Rd., Suite M, N, B-1,
F, Piscataway, NJ
08854.
ANDA 214428............ Niacin extended-release Sciecure Pharma Inc.,
tablet, 500 mg and 1 g. U.S. Agent for
Beijing Sciecure
Pharmaceutical Co.,
Ltd., 138 Glendale
Ave., Edison, NJ
08817.
ANDA 215908............ Nitisinone capsule, 2 Torrent Pharma Inc.,
mg, 5 mg, 10 mg, and 106 Allen Rd., Suite
20 mg. 305, Basking Ridge,
NJ 07920.
ANDA 217094............ Fluphenazine HCl Torrent Pharma Inc.,
tablet, 1 mg, 2.5 mg, U.S. Agent for
5 mg, and 10 mg. Torrent
Pharmaceuticals Ltd.,
106 Allen Rd., Suite
305, Basking Ridge,
NJ 07920.
------------------------------------------------------------------------
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.
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
