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FDA approval activities for this prescription drug:

Mylotarg (Gemtuzumab Ozogamicin) Injection, Wyeth-Ayerst NDA 21-174/S-002 2/23/01 4/23/03 Mylotarg (Gemtuzumab Ozogamicin) Injection, Wyeth-Ayerst NDA 21-174 5/17/00 5/22/00 5/22/00 6/4/01 Mylotarg Indication: for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy.

For the latest approval information, please locate this API using this index.


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