[Federal Register Volume 91, Number 88 (Thursday, May 7, 2026)]
[Notices]
[Pages 24879-24880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-09012]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-4291]
Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of
15 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 15 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of June 8, 2026.
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Table 1--ANDAs for Which Approval Is Withdrawn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 076905............... Finasteride tablet, 1 Teva Pharmaceuticals
milligram (mg). USA, Inc., 400
Interpace Parkway,
Building A,
Parsippany, NJ
07054.
ANDA 077028............... Cilostazol tablet, Actavis Elizabeth
100 mg. LLC. (an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals USA,
Inc.), 400 Interpace
Parkway, Building A,
Parsippany, NJ
07054.
ANDA 077671............... Amlodipine besylate Watson Laboratories,
tablet, Equivalent Inc. (an indirect,
to (EQ) 2.5 mg base, wholly owned
EQ 5 mg base, and EQ subsidiary of Teva
10 mg base. Pharmaceuticals USA,
Inc.), 400 Interpace
Parkway, Building A,
Parsippany, NJ
07054.
ANDA 077679............... Carboplatin Pharmachemie B.V. (an
injectable, 50 mg/5 indirect, wholly
milliliter (mL) (10 owned subsidiary of
mg/mL), 150 mg/15 mL Teva Pharmaceuticals
(10 mg/mL), and 450 USA, Inc.), 400
mg/45 mL (10 mg/mL). Interpace Parkway,
Building A,
Parsippany, NJ
07054.
ANDA 078166............... Ciprofloxacin Par Health USA LLC.,
extended-release U.S. Agent for PH
tablet, 212.6 mg; EQ Health Limited, 9
287.5 mg base and Great Valley
425.2 mg; EQ 574.9 Parkway, Malvern, PA
mg base. 19355.
ANDA 078631............... Carboplatin Pliva Lachema AS (an
injectable, 50 mg/5 indirect, wholly
mL (10 mg/mL), 150 owned subsidiary of
mg/15 mL (10 mg/mL), Teva Pharmaceuticals
450 mg/45 mL (10 mg/ USA, Inc.), 400
mL), and 600 mg/60 Interpace Parkway,
mL (10 mg/mL). MCC Blue Building A,
Parsippany, NJ
07054.
ANDA 078724............... Ezetimibe tablet, 10 Teva Pharmaceuticals
mg. USA, Inc.
ANDA 078984............... Anastrozole tablet, 1 Watson Laboratories,
mg. Inc.
ANDA 089895............... Chlorzoxazone tablet, Barr Laboratories
500 mg. LLC. (an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals USA,
Inc.), 400 Interpace
Parkway, Building A,
Parsippany, NJ
07054.
ANDA 090797............... Pantoprazole sodium Actavis Totowa LLC.
delayed-release (an indirect, wholly
tablet, EQ 20 mg owned subsidiary of
base and EQ 40 mg Teva Pharmaceuticals
base. USA, Inc.), 400
Interpace Parkway,
Building A,
Parsippany, NJ
07054.
ANDA 091539............... Irbesartan and Watson Laboratories,
hydrochlorothiazide Inc.
tablet, 12.5 mg; 150
mg and 12.5 mg; 300
mg.
ANDA 202235............... Ibandronate sodium Freyr INC., U.S.
injectable, EQ 3 mg Agent for CHEMI
base/3 mL. S.p.A., 150 College
Rd. West, Suite 102,
Princeton, NJ 08540.
ANDA 210285............... Dimethyl fumarate Upsher-Smith
delayed-release Laboratories, LLC.,
capsule, 120 mg and U.S. Agent for Sawai
240 mg. USA, Inc., 6701
Evenstad Dr. N,
Suite 300, Maple
Grove, MN 55369.
ANDA 213158............... Esomeprazole The WhiteOak Group,
magnesium delayed- LLC., U.S. Agent for
release pellets Cisen Pharmaceutical
capsule, EQ 20 mg Co., Ltd., 1629 K
base and EQ 40 mg St. NW, Suite 300,
base. Washington, DC
20006.
ANDA 216407............... Ketorolac Parexel
tromethamine tablet, International, U.S.
10 mg. Agent for Atnahs
Pharma US Limited,
541 Church at North
Hills St., Suite
1000, Raleigh, NC
27609.
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[[Page 24880]]
Therefore, approval of the applications listed in Table 1, and all
amendments and supplements thereto, is hereby withdrawn as of June 8,
2026. 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 June 8, 2026 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-09012 Filed 5-6-26; 8:45 am]
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