Aurobindo obtains FDA nod for 2 generics
The Food and Drug Administration has given its blessing to Aurobindo for two generics. One is a generic of Novartis' Gleevec (imatinib mesylate tablets) and the other is a generic of ANI's Arimbex (anastrozole) tablets.
Aurobindo's imatinib mesylate tablets are approved in 100-mg and 400-mg dosage strengths. It is indicated for newly diagnosed adult and pediatric patients with Philadelphia Positive Chronic Myeloid Leukemia; patients with Ph+ CML in Blast Crisis, Accelerated Phase or Chronic Phase After Interferon-alpha therapy; adult patients with Ph+ Acute lymphoblastic leukemia; adult patients with myelodysplastic/myeloproliferative diseases; adult patients with aggressive systemic mastocytosis; adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia; and adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans.
Aurobindo’s anastrozole tablets were approved in 1-mg dosage strength. It is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer; for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer; and for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.