Food and Drug Administration
The committee will discuss new drug application (NDA) 21-824, proposed trade name ZARNESTRA (tipifarnib) Film Coated Tablets, Tibotec Therapeutics, a Division of Ortho Biotech, L.P., proposed indication for the treatment of elderly patients with newly diagnosed poor-risk acute myeloid leukemia.
Tibotec Therapeutics, a Division of Ortho Biotech, L.P.
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