Document ID: FDA-2022-N-0030-0002
Agency: fda
Document Type: Notice
Title: Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications; Correction
Posted Date: 2022-04-19T04:00Z

[Federal Register Volume 87, Number 75 (Tuesday, April 19, 2022)]
[Notices]
[Page 23184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08299]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0030]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register on February 28, 2022. The 
document announced the withdrawal of approval of five abbreviated new 
drug applications (ANDAs) from multiple applicants as of March 30, 
2022. The document indicated that FDA was withdrawing approval of the 
following ANDA after receiving a withdrawal request from Jiangsu 
Hengrui Pharmaceuticals Co., Ltd., U.S. Agent, Venus Pharmaceutical 
Laboratories Inc., 506 Carnegie Center, Suite 100, Princeton, NJ 08540: 
ANDA 091008, Gabapentin Capsules, 100 milligrams (mg), 300 mg, and 400 
mg. Before FDA withdrew the approval of this ANDA, Jiangsu Hengrui 
Pharmaceuticals Co., Ltd., informed FDA that it did not want the 
approval of the ANDA withdrawn. Because Jiangsu Hengrui Pharmaceuticals 
Co., Ltd., timely requested that approval of this ANDA not be 
withdrawn, the approval of ANDA 091008 is still in effect.

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: In the Federal Register of February 28, 2022 
(87 FR 11079), appearing on page 11079 in FR Doc. 2022-04153, the 
following correction is made:
    On page 11079, in the table, the entry for ANDA 091008 is removed.

    Dated: April 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08299 Filed 4-18-22; 8:45 am]
BILLING CODE 4164-01-P