Notice2025-22683
Pfizer Inc., U.S. Agent for King Pharmaceuticals LLC, et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications
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Published
December 12, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
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<title>Federal Register, Volume 90 Issue 237 (Friday, December 12, 2025)</title>
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[Federal Register Volume 90, Number 237 (Friday, December 12, 2025)]
[Notices]
[Pages 57764-57765]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22683]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6077]
Pfizer Inc., U.S. Agent for King Pharmaceuticals LLC, et al.;
Withdrawal of Approval of 20 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 20 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of January 12, 2026.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, <a href="/cdn-cgi/l/email-protection#5e133f2c2a363f7010392b273b301e383a3f7036362d70393128"><span class="__cf_email__" data-cfemail="8ac7ebf8fee2eba4c4edfff3efe4caeceeeba4e2e2f9a4ede5fc">[email protected]</span></a>.
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 040320............ TAPAZOLE (methimazole) Pfizer Inc., U.S.
tablets, 5 milligrams Agent for King
(mg) and 10 mg. Pharmaceuticals LLC,
66 Hudson Blvd. East,
New York, NY 10001.
ANDA 060582............ NEOSPORIN (gramicidin; Pfizer Inc., U.S.
neomycin sulfate; Agent for Monarch
polymyxin B sulfate) Pharmaceuticals, LLC,
solution/drops, 0.025 a subsidiary of
mg/milliliter (mL); Pfizer Inc., 66
Equivalent to (EQ) Hudson Blvd. East,
1.75 mg base/mL; New York, NY 10001.
10,000 units/mL.
ANDA 060707............ NEOSPORIN G.U. Irrigant Do.
(neomycin sulfate;
polymyxin B sulfate)
solution, EQ 40 mg
base/mL; 200,000 units/
mL.
ANDA 062310............ HUMATIN (paromomycin Pfizer Inc., U.S.
sulfate) capsule, EQ Agent for Monarch
250 mg base. Pharmaceuticals, LLC.
ANDA 062414............ Gentamicin Sulfate in Hospira, Inc., 275
sodium chloride 0.9% North Field Dr.,
in plastic container, Building H1-3S, Lake
injectable, EQ 1.2 mg Forest, IL 60045.
base/mL, EQ 1.4 mg
base/mL, EQ 1.6 mg
base/mL, EQ 1.8 mg
base/mL, EQ 2 mg base/
mL, EQ 60 mg base/100
mL, EQ 70 mg base/100
mL, EQ 80 mg base/100
mL, EQ 90 mg base/100
mL, and EQ 100 mg base/
100 mL.
ANDA 063165............ ADRIAMYCIN PFS Pfizer Inc.
(doxorubicin HCl)
injectable, 2 mg/mL
and 200 mg/100 mL.
ANDA 072320............ Pancuronium Bromide Hospira, Inc.
injectable, 1 mg/mL.
ANDA 075221............ ALFENTANIL (alfentanil Do.
HCl) injectable, EQ
0.5 mg base/mL.
ANDA 075458............ Enalaprilat injectable, Do.
1.25 mg/mL.
ANDA 075885............ Milrinone Lactate in Do.
Dextrose 5% in plastic
container, injectable,
EQ 20 mg base/100 mL
(EQ 0.2 mg base/mL)
and EQ 40 mg base/200
mL (EQ 0.2 mg base/mL).
ANDA 076304............ Fluconazole in Dextrose Do.
5% in plastic
container, injectable,
200 mg/100 mL (2mg/mL)
and 400 mg/200 mL (2
mg/mL).
ANDA 077394............ Sodium Bicarbonate Do.
injectable, 0.9
milliequivalent (mEq)/
mL and 1 mEq/mL.
ANDA 089070............ Procainamide HCl Do.
injectable, 500 mg/mL.
ANDA 090621............ Zoledronic Acid Do.
injectable, EQ 4 mg
base/5 mL.
ANDA 202837............ Zoledronic Acid Do.
injectable, EQ 5 mg
base/100 mL.
ANDA 203709............ Fludeoxyglucose F 18 B&H Consulting
injectable, 20-500 Services, Inc., U.S.
millicurie (mCi)/mL. Agent for Wisconsin
Medical
Radiopharmacy, LLC,
50 Division St.,
Suite 206,
Somerville, NJ 08876.
ANDA 203883............ Adenosine solution, 60 Hospira, Inc.
mg/20 mL (3mg/mL) and
90 mg/30 mL (3 mg/mL).
ANDA 204118............ Indomethacin Sodium Do.
injectable, EQ 1 mg
base/vial.
ANDA 208016............ Lurasidone HCl tablets, Watson Laboratories,
20 mg, 40 mg, 60 mg, Inc. (an indirect,
80 mg, and 120 mg. wholly-owned
subsidiary of Teva
Pharmaceuticals USA,
Inc.), 400 Interpace
Parkway, Building A,
Parsippany, NJ 07054.
[[Page 57765]]
ANDA 208833............ Celecoxib capsules, 50 Amneal Pharmaceuticals
mg, 100 mg, 200 mg, of New York, LLC, 50
and 400 mg. Horseblock Rd.,
Brookhaven, NY 11719.
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, are hereby withdrawn as of January
12, 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 January 12, 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.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22683 Filed 12-11-25; 8:45 am]
BILLING CODE 4164-01-P
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