New Delhi, Feb. 1
RANBAXY Laboratories Ltd has received approval from the US Food and Drug Administration to manufacture and market Clarithromycin XL 1000 mg tablets.
The formulation will have the same therapeutic effect as Biaxin XL Filmtab Extended Release tablets 500 mg of Abbott Laboratories. The total annual market sales for oral Clarithromycin were $538.9 million with Biaxin XL accounting for approximately 60 per cent of that market with $320.5 million in sales. Clarithromycin XL tablets are indicated for the treatment of mild to moderate infections. "This 1000 mg dosage form represents a formulation that offers the convenience of a single dose tablet versus Abbott's currently available regimen of two tablets of 500 mg dosed on a once daily basis," said Mr Dipak Chattaraj, President of Ranbaxy.