FDA gives Barr final approval for generic Kytril

MONTVALE, N.J. Barr Laboratories has received final approval from the Food and Drug Administration for its generic version of Kytril, by Roche Laboratories. Kytril is used to prevent nausea and vomiting associated with initial and repeated courses of chemotherapy as well as radiation.

The generic, granisetron hydrochloride, will be available in 1 mg tablets. Barr received final approval for the drug following the expiration of Roche’s patent on Dec. 28. The company plans to launch it immediately.

Kytril had annual sales of about $88 million for the 12 months that ended October 2007, according to IMS sales data.