Caraco Pharmaceutical Laboratories, Ltd., announced that the US Food and Drug Administration (FDA) has granted final approval for the company's abbreviated new drug application (ANDA) for carvedilol tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg (carvedilol).
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of left ventricular dysfunction following myocardial infarction in clinically stable patients, and hypertension. This new product is the bioequivalent to Coreg, a registered trademark of GlaxoSmithKline. Coreg had US sales of approximately $1.59 billion for the 12-month period ended June 30, 2007, according to IMS Data.
Daniel H Movens, Caraco's CEO, said, "We are pleased to receive this approval from the FDA. This marks the fifth approval this quarter in addition to the two tentative approvals we have gained during the period. Our focus continues to be working towards broadening our portfolio by expanding our product offerings as effectively as possible. We plan to market this product immediately. This will bring our total product selection to 39 different products represented by 82 various strengths."