Sun Pharmaceutical Industries on Tuesday said it has got tentative approval from the US drug regulator for generic Gleevec (imatinib meyslate tablets), used in the treatment of chronic myeloid leukaemia.
The US Food and Drug Administration (USFDA) has granted tentative approval for the company’s abbreviated new drug application (ANDA) for generic Gleevec, Sun Pharma said in a filing to the Bombay Stock Exchange (BSE).
The tentatively approved drug (imatinib meyslate tablets) is therapeutically equivalent to Gleevec tablets of Novartis.
The approval of imatinib mesylate tablets are in the strengths of 100 mg and 400 mg.
The annual sales of these tablets are about 950 million dollars in the US.