Natco Pharma files ANDA for Ondansetron

Hyderabad-based Natco Pharma Limited has announced the filing of an Abbreviated New Drug Application (ANDA) with US FDA authorities for its product "� Ondansetron Hydrochloride tablets in two strengths "� 4mg and 8mg.

Natco plans to manufacture the bulk drug required for this product out of its US FDA-approved plant at Mekaguda in Mahabubnagar district, while the finished dosage formulation (tablets) would be manufactured at Natco's US FDA-compliant facility at Kothur.

Ondansetron Hydrochloride is an anti-emetic drug indicated for prevention of nausea and vomiting following chemotherapy, radiation therapy or surgery.

The product was originally approved for marketing in the US in December 1992 and had recorded a global sales of around $1,400 million in 2004. The patent for this product is slated to expire in December 2006, after which the generic version would be introduced.

Natco, on introduction of the product, expects to gain a reasonable share of the generic market, said a company press release.