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Cadila gets USFDA nod for Gatifloxacin

November 29, 2005 17:43 IST
Cadila Healthcare Ltd has received tentative approval from US FDA to market its antibiotic, Gatifloxacin tablets, 200 mg and 400 mg, in the US market.

The company would market the broad-spectrum anti-bacterial drug through its US subsidiary Zydus Pharmaceuticals (USA) Inc, following the patent expiry.

Cadila Healthcare informed the Bombay Stock Exchange that the sales of the tablets in the US market in 2004 were worth $200 million as per NDC Health. Gatifloxacin is used to treat bronchitis, kidney and other urinary tract infections, pneumonia, sinusitis, and certain sexually transmitted diseases.

This marks the 10th Abbreviated New Drug Applications approval for the group since the commencement of filing process in 2003-04.

Since January this year, the group has received approvals for seven products and tentative approvals for three products including Gatifloxacin and so far, the group has filed 28 ANDA and 34 Drug Master Filings.

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