The United States Food and Drug administration (USFDA) has given a green signal to Dr. Reddy to launch its anti-asthmatic drugs in the American market.
Pharmaceutical company Dr. Reddy's Laboratories has launched Zafirlukast tablets, a bioequivalent generic version of Accolate in the US market.
Dr. Reddy's Zafirlukast tablets are available in bottles of 60 counts in 10 mg and 20 mg strengths.
The drug called Zafirlukast will be launched in its abbreviated new drug application (ANDA) after a favourable court judgement in infringement case against it.
The ant-asthmatic drug, Zafirlukast, had a net sale of Rs $50 million in the US market last year ending August31, 2010.