Dr Reddy’s applies for European fondaparinux approval

Dr Reddy's Laboratories has applied for European regulatory approval of generic fondaparinux, a product it is commercialising in partnership with Alchemia.

The company is seeking marketing authorisation for the off-label version of GlaxoSmithKline's Arixtra, a synthetic anticoagulant mainly used for the prevention of deep vein thrombosis (DVT).

It was approved for sale in the US by the Food and Drug Administration and launched in July 2011 by Dr Reddy's, which is assisting Alchemia with the international marketing of its lead compound.

Dr Peter Smith, chief executive officer of Alchemia, said: "This filing comes as expected after the expiry of data exclusivity in Europe and is consistent with Dr Reddy's strategy for the commercialisation of fondaparinux outside of the US."

According to Dr Reddy's most recent financial report, the company generated $522 million (327.48 million pounds) in sales during the three months ending on December 31st 2011.

This represented a 46 percent year-on-year increase, a trend that was underpinned by the launch of 33 new generic therapies during the quarter.