Document ID: FDA-2020-N-1227-0002
Agency: fda
Document Type: Notice
Title: Roerig Division of Pfizer Inc., et al.; Withdrawal of Approval of 10
Abbreviated New Drug Applications; Correction
Posted Date: 2020-09-29T04:00Z

[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Page 61004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21456]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1227]

Roerig Division of Pfizer Inc., 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 July 21, 2020. The document 
announced the withdrawal of approval of 10 abbreviated new drug 
applications (ANDAs) from multiple applicants, withdrawn as of August 
20, 2020. The document indicated that FDA was withdrawing approval of 
the following two ANDAs after receiving a withdrawal request from 
Kadmon Pharmaceuticals, LLC., 119 Commonwealth Dr., Warrendale, PA 
15086: ANDA 076203, Ribavirin Capsules, 200 milligrams (mg) and ANDA 
077456, Ribavirin Tablets, 200 mg, 400 mg, and 600 mg. Before FDA 
withdrew the approval of these ANDAs, Kadmon Pharmaceuticals, LLC. 
informed FDA that it did not want the approval of the ANDAs withdrawn. 
Because Kadmon Pharmaceuticals, LLC., timely requested that approval of 
these ANDAs not be withdrawn, the approval of ANDAs 076203 and 077456 
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, Martha.Nguyen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register of Tuesday, July 21, 2020 (85 FR 44096), 
appearing on page 44096 in FR Doc. 2020-15727, the following correction 
is made:
    On page 44096, in the table, the entries for ANDAs 076203 and 
077456 are removed.

    Dated: September 21, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21456 Filed 9-28-20; 8:45 am]
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