Business OpportunitiesSun Pharma gets tentative FDA nod for generic Gleevec tablets
Sun Pharmaceutical Industries today 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.
- Glenmark Generics gets US FDA nod for Ciclopirox Olamine - Aurobindo gets USFDA nod for hypertension drug - Sun Pharma gains on HC order - HC stops Zydus drug sale on Sun petition - Aurobindo gets USFDA nod for Cefotaxime injection - India Eco Summit: Issues with USFDA to drag on, says Ranbaxy
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.
Shares of Sun Pharmaceutical were trading at Rs 1,451.90, down 1.74 per cent in the morning trade on the BSE.