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[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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of February 14, 2025.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             Table 1--ANDAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
    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
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