Cadila gets tentative FDA OK

Cadila has received tentative approval from USFDA for marketing Carvedilol tablets.

Cadila Healthcare Ltd has received tentative approval from USFDA for marketing Carvedilol tablets of 3.125 mg, 6.25 mg, 12.5 mg and 25 mg in the US market.

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The drug falls in the cardiovascular segment and the current sales of carvedilol tablets in the US market is estimated at $1.24 billion, the company informed the Bombay Stock Exchange.

It had also recently received the tentative approval to market Sertraline Hydrochloride tablets, 25 mg, 50 mg and 100 mg in the US market through its US-based subsidiary Zydus Pharmaceuticals USA Inc.

So far, the group has filed 30 Abbreviated New Drug Applications (ANDAs) and 35 Drug Master Files (DMFs).