Glenmark gets USFDA nod for Ondansetron

Glenmark Pharmaceuticals Inc, the wholly-owned subsidiary of Glenmark Pharmaceuticals, has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Ondansetron Hydrochloride Tablets 4 mg (base), 8 mg (base) and 24 mg (base).

According to a release issued by Glenmark to the BSE today,  Ondansetron Hydrochloride Tablets are the generic version of GlaxoSmithKline's Zofram Tablets.

"Ondansetron Hydrochloride belongs to a category of antiemetics, and is prescribed to help control nausea and vomiting. The drug had annual sales of about $640 million based on IMS data for 12 months ended June 30, 2006," the release added.