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Mylan Inc. subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its generic version of AstraZeneca's Atacand HCT, for the treatment of hypertension, the company said.
Mylan was the first company to have submitted a substantially complete ANDA to the FDA containing a Paragraph IV certification for Candesartan Cilexetil and Hydrochlorothiazide Tablets, 32/25 mg, and was awarded 180 days of generic drug marketing exclusivity for this product strength. Mylan is shipping all approved strengths of this product immediately. Atacand HCT had U.S. sales of $56.3 million for the 12 months ending Sept. 30, 2012, according to IMS Health.