TARO GETS FDA APPROVAL FOR CARVEDILOL, CITALOPRAM

Israel-based Taro Pharmaceutical has received tentative approval from the U.S. FDA for its abbreviated new drug applications (ANDA) for carvedilol tablets. Carvedilol tablets are the generic equivalent of GlaxoSmithKline's Coreg tablets, used in treating cardiovascular conditions such as hypertension.

The company also received final approval from the FDA for its ANDA for citalopram hydrobromide tablets, 10 mg, 20 mg and 40 mg. Taro's citalopram is bioequivalent to Forest Laboratories' Celexa tablets, in the same strengths. Citalopram is indicated for the treatment of depression.