[Federal Register Volume 89, Number 89 (Tuesday, May 7, 2024)]
[Notices]
[Pages 38158-38159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09914]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1917]


Fresenius Kabi USA, LLC, et. al.; Withdrawal of Approval of 12 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of 12 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of June 6, 2024.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New

[[Page 38159]]

Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].

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 040379...............  Fluorouracil Injectable,  Fresenius Kabi
                             50 milligrams (mg)/       USA, LLC, Three
                             milliliter (mL).          Corporate Dr.,
                                                       Lake Zurich, IL
                                                       60047.
ANDA 062901...............  Ampicillin Sodium;        Pfizer Inc., 66
                             Sulbactam Sodium          Hudson Blvd East,
                             Injectable, Equivalent    New York, NY
                             to (EQ) 2 grams (gm)      10001.
                             base/vial; EQ 1 gm base/
                             vial, and EQ 1 gm base/
                             vial; EQ 500 mg base/
                             vial.
ANDA 071981...............  Droperidol Injectable,    Hospira Inc., 275
                             2.5 mg/mL.                North Field Dr.,
                                                       Bldg. H1-3S, Lake
                                                       Forest, IL 60045.
ANDA 202546...............  Ribavirin Tablets, 200    RegCon Solutions,
                             mg, 400 mg, 500 mg, and   LLC, U.S. Agent
                             600 mg.                   for Beximco
                                                       Pharmaceuticals
                                                       USA Inc., 10525
                                                       Vista Sorrento
                                                       Parkway, Suite
                                                       100, San Diego,
                                                       CA 92121.
ANDA 203544...............  Sodium Fluoride F-18      SOFIE Co. dba
                             Injectable, 10-200        SOFIE, 21000
                             millicurie (mCi)/mL.      Atlantic Blvd.,
                                                       Suite 730,
                                                       Dulles, VA 20166.
ANDA 203773...............  Dexmedetomidine           American Regent,
                             Hydrochloride (HCl)       Inc., 5 Ramsey
                             Injectable, EQ 200        Rd., Shirley, NY
                             microgram (mcg) base/2    11967.
                             mL (EQ 100 mcg base/mL).
ANDA 203884...............  Amiodarone HCl            Hospira Inc.
                             Injectable, 50 mg/mL.
ANDA 204315...............  Sodium Fluoride F-18      B&H Consulting
                             Injectable, 10-200 mCi/   Services, Inc.,
                             mL.                       U.S. Agent for
                                                       Shertech
                                                       Laboratories,
                                                       LLC, 50 Division
                                                       St., Suite 206,
                                                       Somerville, NJ
                                                       08876.
ANDA 204366...............  Ammonia N 13 Injectable,  Do.
                             3.75-260 mCi/mL.
ANDA 204854...............  Meropenem for Injection,  Freyr Inc., U.S.
                             500 mg/vial and 1 gm/     Agent for
                             vial.                     Daewoong
                                                       Pharmaceutical
                                                       Co., Ltd., 150
                                                       College Rd. West,
                                                       Suite 102,
                                                       Princeton, NJ
                                                       08540.
ANDA 206710...............  Paricalcitol Capsules, 1  Alvogen PB
                             mcg, 2 mcg, and 4 mcg.    Research and
                                                       Development LLC,
                                                       U.S. Agent for
                                                       Lotus
                                                       Pharmaceutical
                                                       Co., Ltd. Nantou
                                                       Plant, 44
                                                       Whippany Rd.,
                                                       Suite 300,
                                                       Morristown, NJ
                                                       07960.
ANDA 208695...............  Bosentan Tablets, 62.5    Hikma
                             mg, and 125 mg.           Pharmaceuticals
                                                       USA Inc., 1809
                                                       Wilson Rd.,
                                                       Columbus, OH
                                                       43228.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of June 
6, 2024. 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 listed in the table 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 the table that are in inventory on June 6, 2024 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: May 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09914 Filed 5-6-24; 8:45 am]
BILLING CODE 4164-01-P