SpecGX, LLC, et al.; Withdrawal of Approval of 30 Abbreviated New Drug Applications; Correction

概要

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document announced the withdrawal of approval of 30 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of April 29, 2024.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withdrew the approval of these ANDAs, Target Health LLC, informed FDA that it did not want the approval of the ANDAs withdrawn.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Target Health LLC, timely requested that approvals of ANDAs 076280, 077021, 077310, 077517, 206672, and 209550 not be withdrawn, the approvals are still in effect