Glenmark receives US FDA tentative approval to market generic Ondansetron HCL

Glenmark Pharmaceuticals Ltd has announced that Glenmark Pharmaceuticals, Inc, USA (GPI), the wholly owned US subsidiary of the Company, has received tentative approval from the U.S. 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). 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 USD 640 million, based on IMS data for the 12 months ending June 30, 2006.

Source : Equity Bulls

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