Hyderabad-based pharmaceutical major Dr Reddy’s Laboratories today said it has received approval from US health regulator to launch generic Zafirlukast tablet (10 mg and 20 mg), used for treating asthma, in the US market. The Zafirlukast tablets is a bioequivalent generic version of Accolate.
According to IMS Health, the medicine had a total US sales of approximately $50 million for the twelve months ending August 31.
On November 15, 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 today. The company’s tablets are available in bottles of 60 counts. Dr Reddy’s Laboratories had reported 32 per cent rise in consolidated net profit for the second quarter ended September 30 to Rs 286.7 crore, on strong performance in global generic segment.
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