Dr Reddy's gets nod to launch Zafirlukast

Pharmaceutical major Dr Reddy’s Laboratories has launched Zafirlukast tablets (10 mg and 20 mg), a bioequivalent generic version of Accolate in the US market.

Zafirlukast is a prescription medicine used for treating asthma. According to IMS Health, the medicine had total US sales of approximately $50 million for the 12 months ending August 31, 2010.

On November 15, 2010, the US District Court of New Jersey granted Dr Reddy’s motion for summary judgment of non-infringement against AstraZeneca clearing the way for the launch of the product.

Subsequently, the Food & Drug Administration (FDA) approved Dr Reddy’s ANDA (abbreviated new drug application) for Zafirlukast tablets on November 18, the company stated in a press release here on Saturday.

 

The company’s tablets are available in bottles of 60 counts.