[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]
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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.
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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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of February 14, 2025.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Table 1--ANDAs for Which Approval Is Withdrawn
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Application No. Drug Applicant
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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.
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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