Glenmark receives US FDA approval to market generic Ondans

New Delhi, Sep 19 (UNI) Glenmark Pharmaceuticals today said its wholly owned US subsidiary Glenmark Pharmaceuticals (GPI) has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride Tablets for 4 mg, 8 mg and 24 mg dosages.

Ondansetron Hydrochloride tablets are the generic version of GlaxoSmithKline's Zofram Tablets. According to IMS data for the 12 months ending June 30, 2006, the drug had annual sales of about 640 million dollars.

The drug belongs to a category of antiemetics and helps in controlling nausea and vomiting.

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