Mumbai, Nov 20 (IANS) After receiving a regulatory approval from the US Food and Drug Administration (USFDA), pharmaceutical major Dr Reddy’s Laboratories Saturday launched its anti-asthma tablets in the American market.
The approval by the USFDA came after a district court’s decision on the non-infringement of the patent for the tablet. This decision paved the way for the product’s launch.
‘On Nov 15, 2010, the US district court of New Jersey granted Dr Reddy’s motion for summary judgment of non-infringement against Astra Zeneca, clearing the way for the launch of the product,’ the company said in a regulatory filing.
The company said that soon after the judgment Nov 18, USFDA approved Dr Reddy’s new drug application (ANDA) for Zafirlukast tablets.
‘Zafirlukast had total US sales of approximately $50 million for the 12 months ending Aug 31, 2010, according to IMS Health,’ the filing further said.
According to the company, the tablets are available in bottles of 60 counts in 10 mg and 20 mg strengths.