 "Sun Pharma receives US FDA nod for generic Gleevec")
The US Food & Drug Administration (FDA) has approved Sun Pharmaceutical Industries Ltd’s abbreviated new drug application (ANDA) for imatinib mesylate tablets (100 mg and 400 mg), a generic version of Novartis’ Gleevec.
As per IMS MAT August 2015, these tablets have annual sales of approximately $ 2.5 billion in the US. These tablets are indicated for the treatment of chronic myeloid leukemia.
The Sun Pharma subsidiary, being the first-to-file an ANDA for generic Gleevec with a para IV certification, is eligible for 180-days marketing exclusivity in the US. Under the terms of a settlement agreement with Novartis, the Sun Pharma subsidiary is permitted to launch its version of generic Gleevec in the US on February 1, 2016.
As per IMS MAT August 2015, these tablets have annual sales of approximately $ 2.5 billion in the US. These tablets are indicated for the treatment of chronic myeloid leukemia.
The Sun Pharma subsidiary, being the first-to-file an ANDA for generic Gleevec with a para IV certification, is eligible for 180-days marketing exclusivity in the US. Under the terms of a settlement agreement with Novartis, the Sun Pharma subsidiary is permitted to launch its version of generic Gleevec in the US on February 1, 2016.