Mylan Launches Generic of Novartis’ Top-Selling Drug GleevecBy
Mylan has launched imatinib mesylate tablets, 100 mg and 400 mg, a generic version of Novartis’s top-selling drug, Gleevec (imatinib mesylate), an anticancer drug, which had 2016 global sales of $3.3 billion.
Mylan received final approval from the US Food and Drug Administration (FDA) in June 2017 for its abbreviated new drug application for this product, which has multiple indications, including for several blood cancers.
Imatinib mesylate tablets, 100 mg and 400 mg, had US sales of approximately $1.7 billion for the 12 months ending July 31, 2017, according to QuintilesIMS.
Mylan’s tablets were approved of indications for various forms of leukemia and blood cancers.
The indications include: newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; patients with Ph+ CML in blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy; 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 as determined with an FDA-approved test or with c-Kit mutational status unknown; adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown; adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans.