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Entreprise · 31/05/20221 min de lecture
TG Therapeutics, Inc.; Withdrawal of Approval of New Drug Application for UKONIQ (Umbralisib Tosylate) Tablets, Equivalent to 200 Milligrams Base
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Résumé
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for UKONIQ (umbralisib tosylate) Tablets, equivalent to (EQ) 200 milligrams (mg) Base, held by TG Therapeutics, Inc., 3020 Carrington Mill Blvd., Morrisville, NC 27560. TG Therapeutics, Inc. (TGT) has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →