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Lupin generic Hyzaar, Cozaar get final FDA approval

Lupin Pharmaceuticals Inc, the US subsidiary of Lupin Limited, has been granted final approval for the generic versions of Merck's antihypertensive agents Hyzaar (hydrochlorothiazide; losartan potassium) and Cozaar (losartan potassium) by the US Food and Drug Administration (FDA).

The brand products had combined annual sales of $1.6bn in the US, based on IMS sales data for the 12 months ended June 2010.

Mumbai, India-based Lupin Limited produces generic and branded formulations and active pharmaceutical ingredients for the developed and developing markets of the world.

Lupin operates in key markets in the Cardiovascular (prils and statins), Diabetology, Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAIDs therapy segments, in addition to Anti-TB and Cephalosporins.