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Caraco receives FDA approval for cardiovascular drug

Caraco Pharmaceutical Laboratories has received final approval from the FDA for the company's abbreviated new drug application for amlodipine besylate tablets, 2.5mg, 5mg, and 10mg.

Amlodipine is indicated for the treatment of hypertension, for the symptomatic treatment of chronic stable angina, and for the treatment of confirmed or suspected vasospastic angina. Amlodipine is the bioequivalent to Norvasc, a registered trademark of Pfizer.

Daniel Movens, CEO of Caraco, said: “This product marks our seventh final approval since June 30, 2007. We are evaluating the market place and internal production planning in an effort to monetize this approval as soon as possible. This will bring our total product selection to 43 different products represented by 92 various strengths.”