[Federal Register Volume 91, Number 48 (Thursday, March 12, 2026)]
[Notices]
[Page 12199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-04799]
[[Page 12199]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[FDA-2026-N-1226]
Watson Laboratories, 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of April 13, 2026.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Table 1--ANDAs for Which Approval Is Withdrawn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 074316.................. Cimetidine, tablet, Watson
800 milligrams (mg). Laboratories, Inc.
(an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Parkway,
Building A,
Parsippany, NJ
07054.
ANDA 074349.................. Cimetidine, tablet, Do.
200 mg, 300 mg, and
400 mg.
ANDA 074424.................. Cimetidine, tablet, IVAX
200 mg, 300 mg, 400 Pharmaceuticals,
mg, and 800 mg. Inc. (an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Parkway,
Building A,
Parsippany, NJ
07054.
ANDA 074803.................. Fluoxetine Barr Laboratories
hydrochloride LLC (an indirect,
(HCl), capsule, wholly owned
Equivalent to (EQ) subsidiary of Teva
10 mg base and EQ Pharmaceuticals
20 mg base. USA, Inc.), 400
Interpace Parkway,
Building A,
Parsippany, NJ
07054.
ANDA 075062.................. Famotidine, tablet, Watson
20 mg and 40 mg. Laboratories, Inc.
(an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.).
ANDA 075238.................. Sotalol HCl, tablet, Do.
80 mg, 120 mg, 160
mg, and 240 mg.
ANDA 075297.................. Paclitaxel, Teva
injectable, 6 mg/ Pharmaceuticals
milliliters (mL). USA, Inc., 400
Interpace Parkway,
Building A,
Parsippany, NJ
07054.
ANDA 075345.................. Cimetidine, tablet, IVAX
200 mg. Pharmaceuticals,
Inc. (an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.).
ANDA 075353.................. Doxazosin mesylate, Teva
tablet, EQ 1 mg Pharmaceuticals
base, EQ 2 mg base, USA, Inc.
EQ 4 mg base, and
EQ 8 mg base.
ANDA 075425.................. Cimetidine, tablet, Watson
200 mg. Laboratories, Inc.
(an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.).
ANDA 075426.................. Doxazosin mesylate, Do.
tablet, EQ 1 mg
base, EQ 2 mg base,
EQ 4 mg base, and
EQ 8 mg base.
ANDA 075485.................. Gabapentin, capsule, Do.
100 mg, 300 mg, and
400 mg.
ANDA 075574.................. Doxazosin mesylate, Actavis Elizabeth
tablet, EQ 1 mg LLC (an indirect,
base, EQ 2 mg base, wholly owned
EQ 4 mg base, and subsidiary of Teva
EQ 8 mg base. Pharmaceuticals
USA, Inc.), 400
Interpace Parkway,
Building A,
Parsippany, NJ
07054.
ANDA 075632.................. Bisoprolol fumarate IVAX
and Pharmaceuticals,
hydrochlorothiazide Inc. (an indirect,
, tablet, 2.5 mg; wholly owned
6.25 mg, 5 mg; 6.25 subsidiary of Teva
mg, and 10 mg; 6.25 Pharmaceuticals
mg. USA, Inc.).
ANDA 076028.................. Vinorelbine Teva
tartrate, Pharmaceuticals
injectable, EQ 10 USA, Inc.
mg base/mL.
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, are hereby withdrawn as of April
13, 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 April 13, 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. 2026-04799 Filed 3-11-26; 8:45 am]
BILLING CODE 4164-01-P