Document ID: FDA-2020-N-1117-0002
Agency: fda
Document Type: Notice
Title: Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications; Correction
Posted Date: 2020-09-02T04:00Z

[Federal Register Volume 85, Number 171 (Wednesday, September 2, 2020)]
[Notices]
[Page 54581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19364]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1117]

Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 
16 New Drug Applications; Correction

AGENCY: Food and Drug Administration, Health and Human Services (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 May 14, 2020. The document 
announced the withdrawal of approval (as of June 15, 2020) of 16 new 
drug applications (NDAs) from multiple applicants. The document 
indicated that FDA was withdrawing approval of NDA 050641, Monodox 
(doxycycline monohydrate) Capsules, Equivalent to (EQ) 50 milligrams 
(mg) base, EQ 75 mg base, and EQ 100 mg base, after receiving a 
withdrawal request from Aqua Pharmaceuticals, LLC, 707 Eagleview Blvd., 
Suite 200, Exton, PA 19341. Before FDA withdrew the approval of NDA 
050641, Aqua Pharmaceuticals, LLC, informed FDA that it did not want 
the approval of the NDA withdrawn. Because Aqua Pharmaceuticals, LLC, 
timely requested that approval of the NDA not be withdrawn, the 
approval of NDA 050641 is still in effect.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, Kimberly.Lehrfeld@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 14, 2020 (85 
FR 28950), appearing on page 28950 in FR Doc. 2020-10367, the following 
correction is made:
    On page 28951, in the table, the entry for NDA 050641 is removed.

    Dated: August 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19364 Filed 9-1-20; 8:45 am]
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