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Notice

Pfizer Inc., U.S. Agent for King Pharmaceuticals LLC, et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications

A Notice by the Food and Drug Administration on 12/12/2025

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Published Document: 2025-22683 (90 FR 57764)

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2025-N-6077]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of January 12, 2026.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, .

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 § 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 § 314.150(c) is without prejudice to refiling.

Table 1—ANDAs for Which Approval Is Withdrawn
Application No. Drug Applicant
ANDA 040320 TAPAZOLE (methimazole) tablets, 5 milligrams (mg) and 10 mg Pfizer Inc., U.S. Agent for King Pharmaceuticals LLC, 66 Hudson Blvd. East, New York, NY 10001.
ANDA 060582 NEOSPORIN (gramicidin; neomycin sulfate; polymyxin B sulfate) solution/drops, 0.025 mg/milliliter (mL); Equivalent to (EQ) 1.75 mg base/mL; 10,000 units/mL Pfizer Inc., U.S. Agent for Monarch Pharmaceuticals, LLC, a subsidiary of Pfizer Inc., 66 Hudson Blvd. East, New York, NY 10001.
ANDA 060707 NEOSPORIN G.U. Irrigant (neomycin sulfate; polymyxin B sulfate) solution, EQ 40 mg base/mL; 200,000 units/mL Do.
ANDA 062310 HUMATIN (paromomycin sulfate) capsule, EQ 250 mg base Pfizer Inc., U.S. Agent for Monarch Pharmaceuticals, LLC.
ANDA 062414 Gentamicin Sulfate in sodium chloride 0.9% in plastic container, injectable, EQ 1.2 mg 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 Hospira, Inc., 275 North Field Dr., Building H1-3S, Lake Forest, IL 60045.
ANDA 063165 ADRIAMYCIN PFS (doxorubicin HCl) injectable, 2 mg/mL and 200 mg/100 mL Pfizer Inc.
ANDA 072320 Pancuronium Bromide injectable, 1 mg/mL Hospira, Inc.
ANDA 075221 ALFENTANIL (alfentanil HCl) injectable, EQ 0.5 mg base/mL Do.
ANDA 075458 Enalaprilat injectable, 1.25 mg/mL Do.
ANDA 075885 Milrinone Lactate in 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) Do.
ANDA 076304 Fluconazole in Dextrose 5% in plastic container, injectable, 200 mg/100 mL (2mg/mL) and 400 mg/200 mL (2 mg/mL) Do.
ANDA 077394 Sodium Bicarbonate injectable, 0.9 milliequivalent (mEq)/mL and 1 mEq/mL Do.
ANDA 089070 Procainamide HCl injectable, 500 mg/mL Do.
ANDA 090621 Zoledronic Acid injectable, EQ 4 mg base/5 mL Do.
ANDA 202837 Zoledronic Acid injectable, EQ 5 mg base/100 mL Do.
ANDA 203709 Fludeoxyglucose F 18 injectable, 20-500 millicurie (mCi)/mL B&H Consulting Services, Inc., U.S. Agent for Wisconsin Medical Radiopharmacy, LLC, 50 Division St., Suite 206, Somerville, NJ 08876.
ANDA 203883 Adenosine solution, 60 mg/20 mL (3mg/mL) and 90 mg/30 mL (3 mg/mL) Hospira, Inc.
ANDA 204118 Indomethacin Sodium injectable, EQ 1 mg base/vial Do.
ANDA 208016 Lurasidone HCl tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg Watson Laboratories, Inc. (an indirect, wholly-owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Parkway, Building A, Parsippany, NJ 07054.
( printed page 57765)
ANDA 208833 Celecoxib capsules, 50 mg, 100 mg, 200 mg, and 400 mg Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd., Brookhaven, NY 11719.

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

Published Document: 2025-22683 (90 FR 57764)