FDA Approves Three Generic Drugs For Hypertension, Overactive Bladder, Cancer

In recent generic drug developments, the Food and Drug Administration has approved three generic drugs for treating hypertension, overactive bladder, and cancer.

Pittsburgh-based Mylan Inc. Dec. 5 announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval for its version of AstraZeneca’s Atacand HCT (candesartan cilexetil and hydrochlorothiazide) 16/12.5 mg, 32/12.5 mg, and 32/25 mg tablets.

Atacand HCT is indicated for treating hypertension but not for initial therapy.

Mylan said it was the first company to have submitted a substantially complete abbreviated new drug application (ANDA) for the 32/25 mg strength of generic Atacand HCT and was awarded 180 ...