[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Page 52062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13658]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0020]


SpecGX, LLC, et al.; Withdrawal of Approval of 30 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 March 29, 2024. The document 
announced the withdrawal of approval of 30 abbreviated new drug 
applications (ANDAs) from multiple applicants, withdrawn as of April 
29, 2024. The document indicated that FDA was withdrawing approval of 
the following ANDAs after receiving withdrawal requests from Target 
Health LLC, U.S. Agent for CASI Pharmaceuticals, Inc., 450 Commerce 
Blvd., Carlstadt, NJ 07072: ANDA 076280, Tizanidine Hydrochloride (HCl) 
Tablets, Equivalent to (EQ) 2 milligrams (mg) base and EQ 4 mg base; 
ANDA 077021, Cilostazol Tablets, 100 mg; ANDA 077310, Cilostazol 
Tablets, 50 mg; ANDA 077517, Ondansetron HCl Tablets, EQ 4 mg base, EQ 
8 mg base, and EQ 24 mg base; ANDA 206672, Entecavir Tablets, 0.5 mg 
and 1 mg; and ANDA 209550, Tenofovir Disoproxil Fumarate Tablets, 300 
mg. Before FDA withdrew the approval of these ANDAs, Target Health LLC, 
informed FDA that it did not want the approval of the ANDAs withdrawn. 
Because Target Health LLC, timely requested that approvals of ANDAs 
076280, 077021, 077310, 077517, 206672, and 209550 not be withdrawn, 
the approvals are still in effect. This notice 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, 301-
796-3471, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, March 29, 
2024 (89 FR 22155), appearing on page 22155 in FR Doc. 2024-06730, the 
following correction is made:
    On page 22155, in the table, the entries for ANDAs 076280, 077021, 
077310, 077517, 206672, and 209550 are removed.

    Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13658 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P