Mylan launches generic hypertension drug
PITTSBURGH — The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.
Mylan announced the approval and launch of candesartan cilexetil and hydrochlorothiazide tablets in the 16/12.5-mg, 32/12.5-mg and 32/25-mg strengths. Mylan said it was the first company to submit a complete regulatory approval application for the drug and is thus entitled to 180 days of market exclusivity in which to compete directly with the branded version.
The drug is a generic version of AstraZeneca's Atacand HCT, which had sales of $56.3 million during the 12-month period ending in September, according to IMS Health.