Ranbaxy drug gets USFDA approval

Ranbaxy Laboratories has received approval from the U.S. Food and Drug Administration to manufacture and market Clarithromycin XL 1,000 mg tablets.

According to a release issued by the company to the Bombay Stock Exchange on Tuesday, "The office of generic drugs, USFDA, has determined that Ranbaxy's formulation can be expected to have the same therapeutic effect as an equivalent dose of Biaxin XL filmtab extended release tablet 500mg of Abbott Laboratories."

The total annual sales for oral Clarithromycin was $538.9 million. "For the same period, Biaxin XL (Clarithromycin XL 500 mg tablets) accounted for approximately 60 per cent of that market with $320.5 million in sales," the release said.

Dipak Chattaraj, president of Ranbaxy, said, "This 1000 mg dosage form represents a formulation that offers the convenience of a single dose tablet versus the currently (Abbott's) available regimen of two tablets of 500 mg. This is the result of our innovative R&D team and provides ease of administration to patients who might be prescribed this product."

Ranbaxy has already initiated the steps necessary for an expected product launch in May this year, he added.