Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications; Correction
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Abstract
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of this ANDA, Jiangsu Hengrui Pharmaceuticals Co., Ltd., informed FDA that it did not want the approval of the ANDA withdrawn. Because Jiangsu Hengrui Pharmaceuticals Co., Ltd., timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 091008 is still in effect.
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<title>Federal Register, Volume 87 Issue 75 (Tuesday, April 19, 2022)</title>
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[Federal Register Volume 87, Number 75 (Tuesday, April 19, 2022)]
[Notices]
[Page 23184]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08299]
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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.
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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, <a href="/cdn-cgi/l/email-protection#a6ebc7d4d2cec788e8c1d3dfc3c8e6c0c2c788ceced588c1c9d0"><span class="__cf_email__" data-cfemail="0e436f7c7a666f2040697b776b604e686a6f2066667d20696178">[email protected]</span></a>.
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
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