Mylan has launched the generic version of Novartis’s Gleevec tablets, Imatinib Mesylate, in 100mg and 400mg versions in the US.
The launch follows after the company received the final approval from the US Food and Drug Administration (FDA) for the drug’s Abbreviated New Drug Application (ANDA).
The ANDA for Imatinib Mesylate tablets is a kinase inhibitor, and submitted for multiple indications, including for several blood cancers.
The drug has been indicated for treatments of newly diagnosed adult and paediatric patients with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP), in blast crisis (BC), accelerated phase (AP) or in CP after failure of interferon-alpha therapy.
Additional indications among others include adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), as well as adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test.
For the 12 months ending 31 July, Imatinib Mesylate tablets had sales of approximately $1.7bn in the US, according to QuintilesIMS.
About 227 ANDAs are currently pending FDA approval with 45 of them being potential first-to-file opportunities, representing $45.5bn in annual brand sales.
Mylan has an oncology portfolio of more than 40 products and is among the largest suppliers of cancer medicines by volume in the US.
In the US alone, one out of every 13 prescriptions filled is a Mylan brand-name or generic product.