Entreprise · 14/03/20241 min de lecture
Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two 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 on December 18, 2023. The document announced the withdrawal of approval of two new drug applications (NDA), withdrawn as of January 17, 2024. The document indicated that FDA was withdrawing approval of NDA 022424, FLOWTUSS (guaifenesin 200 milligrams (mg)/5 milliliters (mL) and hydrocodone bitartrate 2.5 mg/5 mL) Oral Solution held by Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 10920. Before FDA withdrew the approval of this NDA, Chartwell RX Sciences, LLC informed FDA that it did not want the approval of the NDA withdrawn. Because Chartwell RX Sciences, LLC timely requested that approval of NDA 022424 not be withdrawn, the approval is still in effect. This notice corrects that error.