Document ID: FDA-2023-N-4414-0001
Agency: fda
Document Type: Notice
Title: American Regent, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
Posted Date: 2023-10-19T04:00Z

[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72082-72083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23064]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4414]

American Regent, Inc., et al.; Withdrawal of Approval of Eight 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of November 20, 2023.

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, [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 the 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 040515.....................  Promethazine        American Regent,
                                   Hydrochloride       Inc., 5 Ramsey
                                   Injectable, 25      Rd., Shirley, NY
                                   milligrams (mg)/    11967.
                                   milliliter (mL).
ANDA 080028.....................  Sulfacetamide       Allergan Sales,
                                   Sodium Solution/    LLC, 2525 Dupont
                                   Drops, 10% and      Dr., Irvine, CA
                                   30%.                92612.
ANDA 091300.....................  Riluzole Tablet,    Apotex Corp., U.S.
                                   50 mg.              Agent for Apotex
                                                       Inc., 2400 North
                                                       Commerce Parkway,
                                                       Suite 400,
                                                       Weston, FL 33326.
ANDA 200271.....................  Hydroxyprogesteron  Lachman Consultant
                                   e Caproate          Services, Inc.,
                                   Solution, 1,250     U.S. Agent for
                                   mg/5 mL (250 mg/    Aspen Global
                                   mL).                Inc., 1600
                                                       Stewart Ave.,
                                                       Suite 604,
                                                       Westbury, NY
                                                       11590.
ANDA 201570.....................  Abacavir Sulfate    Apotex Corp., U.S.
                                   Tablet,             Agent for Apotex
                                   Equivalent to       Inc.
                                   (EQ) 300 mg base.

[[Page 72083]]

 
ANDA 202784.....................  Esomeprazole        Hetero USA, Inc.,
                                   Magnesium           U.S. Agent for
                                   Capsule, Delayed    Hetero Labs Ltd.,
                                   Release Pellets,    Unit-III, 1035
                                   EQ 20 mg base and   Centennial Ave.,
                                   EQ 40 mg base.      Piscataway, NJ
                                                       08854.
ANDA 208413.....................  Choline C-11        Washington
                                   Injectable, 4-      University School
                                   33.1 millicurie/    of Medicine, 510
                                   mL.                 South
                                                       Kingshighway
                                                       Blvd., St. Louis,
                                                       MO 63110.
ANDA 208939.....................  Esomeprazole        Hetero USA, Inc.,
                                   Magnesium           U.S. Agent for
                                   Capsule, Delayed    Hetero Labs Ltd.
                                   Release, EQ 20 mg
                                   base.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
November 20, 2023. 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 abbreviated new drug application 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 November 20, 2023 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: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23064 Filed 10-18-23; 8:45 am]
BILLING CODE 4164-01-P