Entreprise · 18/01/20221 min de lecture
Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications; Correction
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Résumé
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 22, 2021. The document announced the withdrawal of approval of 216 abbreviated new drug applications (ANDAs) from multiple applicants, as of November 22, 2021. The document was published with an incorrect date. In addition, the document indicated that FDA was withdrawing approval of ANDA 075941, Strontium Chloride SR-89 Injection, 1 millicurie/milliliter, held by Bio-Nucleonics, Inc., 1600 Market St., Suite 13200, Philadelphia, PA 19103, for repeated failure to submit annual reports. Before FDA withdrew the approval of this ANDA, the application holder informed FDA that it submitted annual reports for ANDA 075941. Therefore, FDA rescinds its withdrawal of approval of ANDA 075941. The approval of ANDA 075941 is still in effect.