Zydus Cadila receives USFDA approval for Paroxetine tablets

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Zydus Cadila has received approval from the US FDA to market Paroxetine Tablets in different strengths of 10 mg, 20 mg, 30 mg and 40 mg. The drug, an anti-depressant falls in the CNS segment. The branded global sales of Paroxetine Tablets was estimated at USD 850 million. The company will market the drug through its US subsidiary Zydus Pharmaceuticals (USA) Inc.

This marks the 19th ANDA approval for the group since the commencement of filing process in FY 2003-04. So far, the group has filed 46 ANDAs and 46 DMFs.

Sourced From: Pressman India