Saturday, November 28, 2009

USFDA grants tentative approval to Sun Pharma's generic version of Gleevec® tablets

The USFDA has granted tentative approval Sun Pharma's 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 leukemia. Gleevec® is a registered trademark of Novartis.

No comments: