Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correction
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Abstract
The Food and Drug Administration (FDA) is correcting a notice entitled "Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications" that appeared in the Federal Register of June 2, 2023. The document announced the withdrawal of approval (as of July 3, 2023) of eight abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of ANDA 077029, Calcipotriene Solution, 0.005% after receiving a withdrawal request from Tolmar, Inc., 701 Centre Ave., Fort Collins, CO 80526. Before FDA withdrew the approval of this ANDA, Tolmar, Inc. informed FDA that it did not want the approval of the ANDA withdrawn. Because Tolmar, Inc. timely requested that approval of ANDA 077029 not be withdrawn, the approval is still in effect. This document corrects that error.
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<title>Federal Register, Volume 88 Issue 184 (Monday, September 25, 2023)</title>
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[Federal Register Volume 88, Number 184 (Monday, September 25, 2023)]
[Notices]
[Page 65691]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20742]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2079]
Hospira, Inc., et al.; Withdrawal of Approval of Eight
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
entitled ``Hospira, Inc., et al.; Withdrawal of Approval of Eight
Abbreviated New Drug Applications'' that appeared in the Federal
Register of June 2, 2023. The document announced the withdrawal of
approval (as of July 3, 2023) of eight abbreviated new drug
applications (ANDAs) from multiple applicants. The document indicated
that FDA was withdrawing approval of ANDA 077029, Calcipotriene
Solution, 0.005% after receiving a withdrawal request from Tolmar,
Inc., 701 Centre Ave., Fort Collins, CO 80526. Before FDA withdrew the
approval of this ANDA, Tolmar, Inc. informed FDA that it did not want
the approval of the ANDA withdrawn. Because Tolmar, Inc. timely
requested that approval of ANDA 077029 not be withdrawn, the approval
is still in effect. This document corrects that error.
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#05486477716d642b4b62707c606b456361642b6d6d762b626a73"><span class="__cf_email__" data-cfemail="6b260a191f030a45250c1e120e052b0d0f0a45030318450c041d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, June 2,
2023 (88 FR 36320), in FR Doc. 2023-11744, the following correction is
made:
On page 36321, in the table, the entry for ANDA 077029 is removed.
Dated: September 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20742 Filed 9-22-23; 8:45 am]
BILLING CODE 4164-01-P
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