Negócios · 13/09/20242 min de leitura
Sandoz Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications; Correction
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Resumo
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 21, 2024. The document announced the withdrawal of approval of 20 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of July 22, 2024. The document indicated that FDA was withdrawing approval of the ANDA 076648 for nitrofurantoin (monohydrate/macrocrystals) capsules, 75 milligrams (mg) and 25 mg, held by Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Rd., East Windsor, NJ 08520; and the ANDA 090723 for duloxetine hydrochloride capsules, delayed-release pellets, Equivalent to (EQ) 20 mg base, EQ 30 mg base, and EQ 60 mg base, held by Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., 150 Motor Pkwy., Suite 401, 4th Floor, Rm. 430, Hauppauge, NY 11788. Before FDA withdrew the approval of these ANDAs, Aurobindo Pharma USA Inc., and Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., informed FDA that they did not want the approval of the ANDAs withdrawn. Because Aurobindo Pharma USA Inc. and Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., timely requested that approval of their respective ANDAs not be withdrawn, the