Sun Pharma announced that the 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 100mg and 400mg.
Imatinib mesylate is used for patients with chronic myeloid leukemia. Gleevec is a registered trademark of Novartis.
India-based Sun Pharma is an international, integrated, speciality pharmaceutical company. It
manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is specialises in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics.