Document ID: FDA-2021-N-0652-0001
Agency: fda
Document Type: Notice
Title: Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications
Posted Date: 2021-07-28T04:00Z

[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40591-40592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16047]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0652]

Fresenius Kabi USA, LLC, 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of August 27, 2021.

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, Martha.Nguyen@fda.hhs.gov.

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 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.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040265.................  Methotrexate Sodium   Fresenius Kabi USA,
                               Injection,            LLC, Three
                               Equivalent to (EQ)    Corporate Dr., Lake
                               25 milligrams (mg)    Zurich, IL 60047.
                               base/milliliters
                               (mL).
ANDA 070963.................  Clonidine             Watson Laboratories,
                               Hydrochloride (HCl)   Inc. (an indirect,
                               Tablets, 0.3 mg.      wholly owned
                                                     subsidiary of Teva
                                                     Pharmaceuticals
                                                     USA, Inc.), 400
                                                     Interpace Pkwy.,
                                                     Bldg. A,
                                                     Parsippany, NJ
                                                     07054.
ANDA 074292.................  Dobutamine HCl        Hospira, Inc., 275
                               Injection, EQ 12.5    North Field Dr.,
                               mg base/mL.           Bldg. H1, Lake
                                                     Forest, IL 60045.
ANDA 075069.................  Etodolac Tablets,     Watson Laboratories,
                               400 mg.               Inc.
ANDA 075856.................  Midazolam HCl         Hospira, Inc.
                               Injection, EQ 1 mg
                               base/mL and EQ 5 mg
                               base/mL.
ANDA 084504.................  Hydralazine HCl       Watson Laboratories,
                               Tablets, 25 mg.       Inc.
ANDA 090379.................  Budesonide Delayed    Barr Laboratories,
                               Release Capsules, 3   Inc. (an indirect,
                               mg.                   wholly owned
                                                     subsidiary of Teva
                                                     Pharmaceuticals
                                                     USA, Inc.), 400
                                                     Interpace Pkwy.,
                                                     Bldg. A, Morris
                                                     Corporate Center
                                                     III, Parsippany, NJ
                                                     07054.
ANDA 091590.................  Losartan Potassium    Mylan
                               Tablets, 25 mg, 50    Pharmaceuticals
                               mg, and 100 mg.       Inc., a Viatris
                                                     Company, 81
                                                     Chestnut Ridge Rd.,
                                                     P.O. Box 4310,
                                                     Morgantown, WV
                                                     26504.
ANDA 091652.................  Hydrochlorothiazide   Do.
                               and Losartan
                               Potassium Tablets,
                               12.5 mg/50 mg, 12.5
                               mg/100 mg, and 25
                               mg/100 mg.
ANDA 204361.................  Eptifibatide          USV Private Limited,
                               Injection, 2 mg/mL    U.S. Agent, Omega
                               and 75 mg/100 mL.     Pharmaceutical
                                                     Consulting, Inc.,
                                                     752 West Shuhthagi
                                                     Lane, New Harmony,
                                                     UT 84757.
ANDA 204362.................  Eptifibatide          Do.
                               Injection, 2 mg/mL.

[[Page 40592]]

 
ANDA 204464.................  Sodium Fluoride F-18  Decatur Memorial
                               Injection, 10-200     Hospital, 2300
                               millicurie/mL.        North Edward St.,
                                                     Suite 100, Decatur,
                                                     IL 62526.
ANDA 206177.................  Docetaxel Injection,  DFB Oncology, LLC,
                               20 mg/mL (20 mg/      3909 Hulen St.,
                               mL), 80 mg/4 mL (20   Fort Worth, TX
                               mg/mL), and 200 mg/   76107.
                               10 mL (20 mg/mL).
ANDA 206631.................  Olmesartan Medoxomil  Lupin Limited, U.S.
                               Tablets, 5 mg, 20     Agent, Lupin
                               mg, and 40 mg.        Pharmaceuticals,
                                                     Inc., 111 South
                                                     Calvert St.,
                                                     Harborplace Tower,
                                                     21st Floor,
                                                     Baltimore, MD
                                                     21202.
ANDA 209399.................  Olanzapine Tablets,   Jiangsu Hansoh
                               2.5 mg, 5 mg, and     Pharmaceutical
                               10 mg.                Group Co., Ltd.,
                                                     U.S. Agent, eVenus
                                                     Pharmaceutical
                                                     Laboratories Inc.,
                                                     506 Carnegie
                                                     Center, Suite 100,
                                                     Princeton, NJ
                                                     08540.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
August 27, 2021. 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 August 27, 2021 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: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16047 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P