The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for generic Atacand HCT tablets to treat hypertension.
Candesartan Cilexetil and Hydrochlorothiazide Tablets in 16/12.5mg, 32/12.5mg and 32/25mg strenghts, for which the company began shipment, are equivalent to AstraZeneca's Atacand HCT medication.
The fixed dose drug combination is not meant for early treatment of high blood pressure.
Mylan obtained 180-day marketing exclusivity for 32/25mg strength of generic drug Candesartan Cilexetil and Hydrochlorothiazide tablets.
IMS Health has reported US sales of $56.3m for the 12 months ending 30 September 2012 for Atacand HCT, a combination of candesartan cilexetil, an angiotensin II receptor blocker, and hydrochlorothiazide, a diuretic.
