Hyzaar is a combination medication used in the treatment of high blood pressure. One component, losartan, belongs to a new class of blood pressure medications that work by preventing the hormone angiotensin II from constricting the blood vessels, thus allowing blood to flow more freely and keeping the blood pressure down.
The other component, hydrochlorothiazide, is a diuretic that increases the output of urine, removing excess fluid from the body and thus lowering blood pressure.
Mylan Pharmaceuticals has also received tentative approval for the 50mg/12.5mg and 100mg/25mg strengths, which are eligible for final approval on or around Oct. 4, 2010, upon the expiration of the first-to-file 180-day exclusivity period.
According to IMS Health, currently, Mylan has 141 ANDAs pending FDA approval. Thirty-eight of these pending ANDAs are potential first-to-file opportunities.