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Watson Laboratories, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of eight abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the...

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2022-N-0074]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is withdrawing approval of eight 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of March 4, 2022.

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, 240-402-6980, .

SUPPLEMENTARY INFORMATION:

The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described 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.

Application No. Drug Applicant
ANDA 075152 Diclofenac Potassium Tablets, 50 milligrams (mg) Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Bldg. A, Parsippany, NJ 07054.
ANDA 091376 Topotecan Hydrochloride (HCl) for Injection, Equivalent to (EQ) 4 mg base/vial Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
ANDA 091471 Efavirenz Tablets, 600 mg Mylan Pharmaceuticals Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505.
ANDA 200463 Itraconazole Capsules, 100 mg Mylan Pharmaceuticals Inc., a Viatris Company, 781 Chestnut Ridge Rd., Morgantown, WV 26504.
ANDA 202395 Ziprasidone HCl Capsules, EQ 20 mg base, EQ 40 mg base, EQ 60 mg base, and EQ 80 mg base Do.
ANDA 203170 Docetaxel Injection, 40 mg/milliliter Jiangsu Hengrui Pharmaceuticals Co., Ltd., U.S. Agent, eVenus Pharmaceutical Laboratories Inc., 506 Carnegie Center, Suite 100, Princeton, NJ 08540.
ANDA 203574 Mesalamine Delayed Release Tablets, 1.2 grams Mylan Pharmaceuticals Inc., a Viatris Company, 781 Chestnut Ridge Rd., Morgantown, WV 26504.
ANDA 208177 Atazanavir Sulfate Capsules, EQ 150 mg base, EQ 200 mg base, and EQ 300 mg base Do.
( printed page 5829)

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of March 4, 2022. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on March 4, 2022 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 25, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2022-02053 Filed 2-1-22; 8:45 am]

BILLING CODE 4164-01-P

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87 FR 5828

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“Watson Laboratories, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications,” thefederalregister.org (February 2, 2022), https://thefederalregister.org/documents/2022-02053/watson-laboratories-inc-et-al-withdrawal-of-approval-of-eight-abbreviated-new-drug-applications.