Sun Pharma announced that the US FDA has granted tentative approval to an Abbreviated New Drug Application (ANDA) for generic Gleevec, imatinib mesylate tablets.
These imatinib mesylate tablets, therapeutically equivalent to Gleevec tablets from Novartis, have two strengths viz. 100 mg and 400 mg and have annual sales of approximately USD 950 million in the US.
Imatinib mesylate is used for patients with chronic myeloid leukaemia.
Gleevec is a registered trademark of Novartis.