Lupin launches generic Gleevec
Lupin is introducing its generic Gleevec (imatinib mesylate tablets) in two dosage strengths. Lupin's alliance partner Natco had previously received the Food and Drug Administration's approval for the generic of Novartis' branded drug in 100- and 400-mg dosage strengths.
It is indicated for the treatment of various cancers, including newly diagnosed adult and pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia; adult patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia; adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor gene re-arrangements as determined with an FDA-approved test; adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown; adult patients with certain types of hypereosinophilic syndrome and/or chronic eosinophilic leukemia; and adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans.
Imatinib mesylate tablets had a market value of roughly $548 million, according to IQVIA May 2019 data.
It is indicated for the treatment of various cancers, including newly diagnosed adult and pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia; adult patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia; adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor gene re-arrangements as determined with an FDA-approved test; adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown; adult patients with certain types of hypereosinophilic syndrome and/or chronic eosinophilic leukemia; and adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans.
Imatinib mesylate tablets had a market value of roughly $548 million, according to IQVIA May 2019 data.