Zydus Cadila has received tentative approval from the US FDA to market Carvedilol Tablets 3.125 mg, 6.25 mg, 12.5 mg and 25 mg., in the US market. The drug falls in the Cardiovascular segment. The current sales of Carvedilol Tablets in the US market as per NDC Health is estimated at USD 1.24 bn.
The group had recently received the tentative approval to market Sertraline Hydrochloride Tablets, 25 mg, 50 mg and 100 mg., in the US market through its US subsidiary Zydus Pharmaceuticals USA Inc. So far, the group has filed 30 ANDAs and 35 DMFs.