Allergan Sales LLC., et. al.; Withdrawal of Approval of 10 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 November 21, 2022. The document announced the withdrawal of approval (as of December 21, 2022) of 10 abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of the following ANDAs after receiving withdrawal requests from Sunstar Americas, Inc., 301 East Central Rd., Schaumburg, IL 60195: ANDA 076434, Chlorhexidine Gluconate Solution, 0.12%; Sofgen Pharmaceuticals, LLC, 21500 Biscayne Blvd., Suite 600, Aventura, FL 33180: ANDA 201832, Nimodipine Capsules, 30 milligrams (mg); and Indicus Pharma, LLC, 2530 Meridian Parkway, Durham, NC 27713: ANDA 203419, Donepezil HCl Tablets, 23 mg. Before FDA withdrew the approval of these ANDAs, Sunstar Americas, Inc., Sofgen Pharmaceuticals, LLC, and Indicus Pharma, LLC informed FDA that they did not want the approval of the ANDAs withdrawn. Because Sunstar Americas, Inc. timely requested that approval of ANDA 076434 not be withdrawn, Sofgen Pharmaceuticals, LLC timely requested that the approval of ANDA 201832 not be withdrawn, and Indicus Pharma, LLC timely requested that the approval of ANDA 203419 not be withdrawn, the approvals are still in effect.
Full Text
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<title>Federal Register, Volume 88 Issue 22 (Thursday, February 2, 2023)</title>
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[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Notices]
[Page 7091]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02155]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2826]
Allergan Sales LLC., et. al.; Withdrawal of Approval of 10
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 November 21, 2022. The
document announced the withdrawal of approval (as of December 21, 2022)
of 10 abbreviated new drug applications (ANDAs) from multiple
applicants. The document indicated that FDA was withdrawing approval of
the following ANDAs after receiving withdrawal requests from Sunstar
Americas, Inc., 301 East Central Rd., Schaumburg, IL 60195: ANDA
076434, Chlorhexidine Gluconate Solution, 0.12%; Sofgen
Pharmaceuticals, LLC, 21500 Biscayne Blvd., Suite 600, Aventura, FL
33180: ANDA 201832, Nimodipine Capsules, 30 milligrams (mg); and
Indicus Pharma, LLC, 2530 Meridian Parkway, Durham, NC 27713: ANDA
203419, Donepezil HCl Tablets, 23 mg. Before FDA withdrew the approval
of these ANDAs, Sunstar Americas, Inc., Sofgen Pharmaceuticals, LLC,
and Indicus Pharma, LLC informed FDA that they did not want the
approval of the ANDAs withdrawn. Because Sunstar Americas, Inc. timely
requested that approval of ANDA 076434 not be withdrawn, Sofgen
Pharmaceuticals, LLC timely requested that the approval of ANDA 201832
not be withdrawn, and Indicus Pharma, LLC timely requested that the
approval of ANDA 203419 not be withdrawn, the approvals are 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#8cc1edfef8e4eda2c2ebf9f5e9e2cceae8eda2e4e4ffa2ebe3fa"><span class="__cf_email__" data-cfemail="2865495a5c404906664f5d514d46684e4c490640405b064f475e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, November
21, 2022 (87 FR 223), in FR Doc. 2022-25315, the following correction
is made:
On page 70835, in the table, the entries for ANDAs 076434, 201832,
and 203419 are removed.
Dated: January 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02155 Filed 2-1-23; 8:45 am]
BILLING CODE 4164-01-P
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