Tentative US FDA approval for Zydus Cadila's gatifloxacin tablets

Mumbai: Cadila Healthcare Ltd has received tentative approval from the US FDA to market Gatifloxacin Tablets, 200mg and 400mg, a broad spectrum anti-bacterial agent, in the US market.

The sales in 2004 of Gatifloxacin Tablets in the US market are estimated at $200 million. The company will market the drug through its US subsidiary Zydus Pharmaceuticals (USA) Inc, following patent expiry.

This marks the tenth ANDA approval for the group since the commencement of filing process in FY 2003-04. Starting from January this year, the group has received approvals for seven products and tentative approvals for three products including Gatifloxacin. So far, the group has filed 28 ANDAs and 34 DMFs.