Dr Reddy's gets USFDA nod to launch anti-asthma tablets in US

The approval by the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Zafirlukast tablets follows a favourable court judgment in the patent infringement case filed against it by patent holder Astra Zeneca.

The US District Court of New Jersey had "granted the motion for summary judgment of non-infringement against Astra Zeneca clearing the way for the launch of the product" on November 15, the company said in a filing to the Bombay Stock Exchange (BSE).

Subsequently on November 18, US FDA approved Dr Reddy's ANDA for Zafirlukast tablets, generic version of Astra Zeneca's Accolate tablets, in the strengths of 10 mg and 20 mg, it added.

According to IMS health, Zafirlukast tablets had total sales of around USD 50 million in the US market for twelve months ended August 31, 2010, it said.

Dr Reddy's Laboratories had reported 32 per cent rise in consolidated net profit for the second quarter ended September 30, 2010, to Rs 286.7 crore on strong performance in global generic segment.