In a major boost to Ranbaxy Laboratories' exports to developed countries, the United States has approved marketing of flecainide acetate tablets in the country.
The US Food and Drug Administration allowed the Indian pharma major to market the drug in 50mg, 100 mg and 150 mg strengths after the Indian product was found bioequivalent and therapeutically equivalent to the listed drug Tambocor, a media release said.
The total sales of flecainide acetate tablets grossed $105.6 million, it said.
The product would be available through wholesalers and dispensing outlets throughout the US. Flecainide will be manufactured in the US at Ohm Laboratories, RLL's facility located in New Jersey, the release added.