July 2, 2010 / 8:31 PM / in 8 years

UPDATE 1-Impax files for generic version of Genzyme's Renvela

* The drug treats excess phosphate in the blood

July 2 (Reuters) - Impax Laboratories Inc’s (IPXL.O) said it has filed with U.S. regulators seeking marketing approval for a generic version of Genzyme Corp’s GENZ.O drug Renvela.

The drug treats hyperphosphatemia, or excess phosphate in the blood, which increases the risk of cardiovascular disease in patients with chronic kidney disease.

On July 1, Genzyme filed suit for patent infringement against Impax in a U.S. District Court.

The filing of an abbreviated new drug application (ANDA) with the U.S Food and Drug Administration includes a paragraph IV certification for a generic version of Renvela 2.4 g and 0.8 g, the company said in a statement.

Paragraph IV certification gives a 180-day exclusivity to market a generic to companies that are the “first-to-file” an ANDA.

    Upon regulatory approval, Impax’s generic division, Global Pharmaceuticals, will commercialize the products, the company said.

    Shares of Impax closed at $18.07 Friday on Nasdaq. (Reporting by Shailesh Kuber in Bangalore; Editing by Vyas Mohan)

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