East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Imatinib Mesylate Tablets, 100 mg and 400 mg. Aurobindo’s Imatinib Mesylate Tablets, 100 mg and 400 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Gleevec Tablets, 100 mg and 400 mg, of Novartis Pharmaceuticals Corporation.

Imatinib Mesylate Tablets are indicated for:

1. Newly Diagnosed adult and pediatric patients with Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML)
2. Patients with Ph+ CML in Blast Crisis (BC), Accelerated Phase (AP) or Chronic Phase (CP) After Interferon-alpha (IFN) Therapy
3. Adult patients with Ph+ Acute Lymphoblastic Leukemia (ALL)
4. Adult patients with Myelodysplastic/Myeloproliferative Diseases (MDS/MPD)
5. Adult patients with aggressive systemic mastocytosis
6. Adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia
7. Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans