|
|
|
 |
FDA Approval Activities for this 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. Mylotarg (Gemtuzumab Ozogamicin) Injection, Wyeth Pharmaceuticals Mylotarg (gemtuzumab ozogamicin) for Injection, Wyeth Pharmaceuticals 21-174/S-012,-014 Mylotarg (gemtuzumab ozogamicin) for Injection, Wyeth Pharmaceuticals, Package Change | Mylotarg (gemtuzumab ozogamicin) Injection, Wyeth Pharma, Labeling Revision | Mylotarg (gemutuzumab ozogamicin) Injection, Wyeth Pharma, Labeling Revision | Mylotarg (gemtuzumab ozogamicin) Injection, Wyeth Pharma, Efficacy Sup w/Clinical Data
  
|