Green Light for Mylan (MYL) Generic Version of Atacand HCT(R)
12/05/2012

** Mylan Inc. (Nasdaq:MYL) reported that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug-Administration (FDA) for its Abbreviated New Drug-Application (ANDA) for Candesartan Cilexetil and Hydrochlorothiazide Tablets, 16/12.5

Online PR News – 05-December-2012 – Las Vegas, NV – MYL, Mylan Inc.

MYL reported that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. 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. This product is the generic version of AstraZeneca's Atacand HCT(R), and is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy. Atacand HCT had U.S. sales of $56.3 million for the 12 months ending Sept. 30, 2012, according to IMS Health. MYL 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. MYL is shipping all approved strengths of this product immediately. MYL is a global pharmaceutical company committed to setting new standards in health care. More about MYL at www.mylan.com

Read full disclaimer at http://pennygovernance.com/disclaimer