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Imprese · 18/12/20231 min di lettura
Pharmacyclics LLC.; Withdrawal of Approval of Indications for Mantle Cell Lymphoma and Marginal Zone Lymphoma for IMBRUVICA (ibrutinib) Capsules and Tablets
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
The Food and Drug Administration (FDA or Agency) is announcing that it is withdrawing approval of the indications for mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) for IMBRUVICA (ibrutinib) Capsules and Tablets approved, respectively, under new drug applications (NDAs) 205552 and 210563. These NDAs are held by Pharmacyclics LLC, 1000 Gateway Blvd., South San Francisco, CA 94080 (Pharmacyclics). Pharmacyclics voluntarily requested that the Agency withdraw approval of these indications and waived its opportunity for a hearing.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →