Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 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 of October 22, 2021. The document announced the withdrawal of approval of 216 abbreviated new drug applications (ANDAs) from multiple applicants, as of November 22, 2021. The document was published with an incorrect date. In addition, the document indicated that FDA was withdrawing approval of ANDA 075941, Strontium Chloride SR-89 Injection, 1 millicurie/milliliter, held by Bio-Nucleonics, Inc., 1600 Market St., Suite 13200, Philadelphia, PA 19103, for repeated failure to submit annual reports. Before FDA withdrew the approval of this ANDA, the application holder informed FDA that it submitted annual reports for ANDA 075941. Therefore, FDA rescinds its withdrawal of approval of ANDA 075941. The approval of ANDA 075941 is still in effect.
Full Text
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<title>Federal Register, Volume 87 Issue 11 (Tuesday, January 18, 2022)</title>
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[Federal Register Volume 87, Number 11 (Tuesday, January 18, 2022)]
[Notices]
[Page 2616]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00831]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1037]
Fresenius USA, Inc., et al.; Withdrawal of Approval of 216
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 of October 22, 2021. The document
announced the withdrawal of approval of 216 abbreviated new drug
applications (ANDAs) from multiple applicants, as of November 22, 2021.
The document was published with an incorrect date. In addition, the
document indicated that FDA was withdrawing approval of ANDA 075941,
Strontium Chloride SR-89 Injection, 1 millicurie/milliliter, held by
Bio-Nucleonics, Inc., 1600 Market St., Suite 13200, Philadelphia, PA
19103, for repeated failure to submit annual reports. Before FDA
withdrew the approval of this ANDA, the application holder informed FDA
that it submitted annual reports for ANDA 075941. Therefore, FDA
rescinds its withdrawal of approval of ANDA 075941. The approval of
ANDA 075941 is still in effect.
FOR FURTHER INFORMATION CONTACT: James Hanratty, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-
402-4718, <a href="/cdn-cgi/l/email-protection#82c8e3efe7f1accae3ecf0e3f6f6fbc2e4e6e3aceaeaf1ace5edf4"><span class="__cf_email__" data-cfemail="8bc1eae6eef8a5c3eae5f9eafffff2cbedefeaa5e3e3f8a5ece4fd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Corrections
In the Federal Register of Friday, October 22, 2021 (86 FR 58675),
in FR Doc. 2021-23075, the following corrections are made:
1. On page 58675, in the second column, correct the DATES section
to read: DATES: Approval is withdrawn as of October 22, 2021.''
2. On page 58679, in the table, remove the entry for ANDA 075941.
Dated: January 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00831 Filed 1-14-22; 8:45 am]
BILLING CODE 4164-01-P
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