Mylan Pharmaceuticals Inc., subsidiary of Mylan Inc. has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Candesartan Cilexetil and Hydrochlorothiazide tablets, 16/12.5 mg, 32/12.5 mg and 32/25 mg. Candesartan Cilexetil and Hydrochlorothiazide tablets is the generic version of AstraZeneca's Atacand HCT, and is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy.
Mylan was the first company to have submitted a substantially complete ANDA to the US 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 US sales of $56.3 million for the 12 months ending Sept. 30, 2012, according to IMS Health.
Currently, Mylan has 178 ANDAs pending FDA approval representing $80.1 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $21.2 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.
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