Caraco gets FDA OK for generic Norvasc

Detroit, USA-based Caraco Pharmaceutical Laboratories says that the Food and Drug Administration has granted final approval for its generic version of Pfizer's Norvasc (amlodipine besylate). The clearance, which is for an Abbreviated New Drug Application covering 2.5mg, 5mg and 10mg doses, is for use of the agent in the treatment of hypertension, chronic unstable and vasospastic angina.

Daniel Movens, Caraco's chief executive, said "this product marks our seventh final approval since June, 2007. We are evaluating the market place and internal production planning in an effort to monetize this approval as soon as possible."