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. |
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Ondansetron Hydrochloride is an anti-emetic drug indicated for prevention of nausea and vomiting following chemotherapy, radiation therapy or surgery. |
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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. |
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Natco, on introduction of the product, expects to gain a reasonable share of the generic market, said a company press release. |
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